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Book Excerpt: Fundamentals of US Regulatory Affairs, Ninth Edition, Chapter 41: Regulatory Information Resources in Review

Posted 11 August 2015 | By Auresa Thomas, PhD, RAC 

Book Excerpt: Fundamentals of US Regulatory Affairs, Ninth Edition, Chapter 41: Regulatory Information Resources in Review

The following chapter is an excerpt taken from Fundamentals of US Regulatory Affairs, Ninth Edition

OBJECTIVES

  • Become familiar with information resources relevant to the healthcare regulatory industry
  • Learn where to access and retrieve publicly available government, industry and association resources to build regulatory intelligence
  • Recognize the value of meetings and continued learning programs available for professional knowledge and development

Introduction

Two persistent challenges for the regulatory professional include remaining informed and dealing with constant change. The regulatory profession is characterized by both lateral job changes and promotions, as well as frequent mergers among pharmaceutical, medical device and biologics companies. In addition, it is not uncommon for a regulatory professional’s career to begin in the pharmaceutical industry and then transition to the device arena, or for professionals to switch from devices to combination products. The regulatory field’s dynamics, in terms of internal personnel moves, external enterprise decisions and changes to the regulatory landscape, require vigilance to stay abreast of healthcare industry information. As such, proactive management of information resources is a valuable objective for a regulatory team concerned with functioning effectively to maintain regulatory compliance. In addition, within the regulatory field, the transition to digital transactions and electronic data has resulted in increased reliability, trustworthiness, usability and portability of online information technology tools.

Given the fluidity of the regulatory environment, both domestically and globally, the regulatory professional is expected to know how to synthesize dynamic information and develop regulatory strategy based on multiple information streams: print (e.g., books and magazines), static electronic (e.g., e-newsletters and government websites) and interactive electronic resources (i.e., social medial and webinars). This chapter discusses the value of each information stream and provides a comprehensive review of resources available to build US regulatory intelligence and support product substantiation.

Regulatory Intelligence

US Governing Law

An integral component of a regulatory professional’s work is to stay informed of the latest regulatory and legislative developments. This section reviews readily accessible electronic regulatory and legislative documents.

The Government Printing Office (GPO) is the official federal bookstore for US government publications. GPO is the primary resource for gathering, cataloging, producing, providing, authenticating and preserving published information in all its forms for the executive, legislative and judicial branches of the federal government.1 Publications pertaining to regulatory healthcare topics may be accessed through a search using the keywords “FDA” or “Food and Drug Administration” and “DHHS” or “Department of Health & Human Services” combined with more specific terms such as “pharmaceutical,” “clinical” or “drug industry.” GPO’s Federal Digital System (FDsys) provides free electronic access to legislative resources, including Congressional bills, the Congressional Record, public and private law and the US Code; executive sources, such as the Code of Federal Regulations (CFR), the Federal Register (FR) and presidential materials; and judicial sources, including the Supreme Court, trial and appellate court cases, opinions, oral arguments and decisions.

The FR, published daily (except on weekends and federal holidays) by the Office of the Federal Register, National Archives and Records Administration, and made accessible by GPO, serves as the official daily publication for rules, proposed rules, executive orders, presidential documents and federal agency and organization notices. The 2015 FR is Volume 80 and may be searched separately or in conjunction with prior years dating back to 1994 (Volume 59). Individuals also may register for a free daily email containing the FR table of contents.2 The CFR codifies general and permanent rules published in the FR, and is divided into 50 titles representing broad areas subject to federal regulation. Each CFR volume is updated yearly and issued quarterly. Titles are divided into chapters, usually bearing the issuing agency’s name. Chapters, in turn, are subdivided into parts covering specific regulatory areas (e.g., 21 CFR 316.24 = Title 21—Food and Drugs, Chapter I—Food and Drug Administration, Department of Health and Human Services, Subchapter D—Drugs for Human Use, Part 316—Orphan Drugs, Subpart C—Designation of an Orphan Drug, Section 316.24—Granting orphan-drug designation.). CFR records on FDsys span 1996 to the current year. Documents are available as ASCII text, HTML and PDF files.3

In addition to the FR and CFR, FDsys provides access to numerous databases, including the Congressional Record, the US Code, Congressional bills, Statutes at Large and public and private laws. FDsys serves as the official source of legislation and regulations; however, reference information for FDA legislation, rules, regulations, guidance documents, administrative FDA proceedings and rule-making documents, standards and the electronic reading room reside on FDA’s website.4 The electronic reading room provides a collection of publicly releasable FDA agency records. FDA manages dockets, administrative FDA proceedings and rule-making documents, through a searchable Federal Dockets Management System (FDMS). The FDMS allows the public to search and download documents and post feedback to agencies.5 In 1995, the Library of Congress created the THOMAS database at the direction of the 104th Congress to make federal legislation publicly available. THOMAS offers a vast range of government resources, including databases to search bill resolutions; bill and amendment summaries; bills across multiple Congresses; public laws searchable by number; House and Senate roll call votes; legislation by sponsor; congressional activity databases; the Congressional Record; days-in-session calendars; committee reports; and treaties.6

Importers and exporters of FDA-regulated products must be familiar with applicable US trade laws. These products are regulated by the Federal Food, Drug, and Cosmetic Act (FD&C Act), per Chapter VIII: FDA Imports and Exports, the FD&C Act, Sections 801 and 802, the US Code (as it relates to the FD&C Act, patent infringement and several additional matters), CFR (Title 21) and US Customs and Border Protection (CBP) regulations.

CBP, a bureau of the Department of Homeland Security, regulates and enforces US regulations on trade and customs. It maintains a trademark recording system, Intellectual Property Rights Search (IPRS) database, for trademarks registered with the US Patent and Trademark Office (PTO).7 The CBP website also provides a searchable repository of FR notices related to product importation into the US. The Customs Rulings Online Search System (CROSS) is a database allowing the retrieval of trade-related rulings and legal decisions issued by CBP from 1989 to present.8 In 2011, CBP released a “Letter to Industry” to review the medical and non-medical radiation-emitting electronic product import entry review process. The letter discusses the voluntary use of Affirmations of Compliance (AofC) codes during the import entry process to provide product identification and show compliance with specific FDA product requirements.9 CBP resources support a company’s efforts to enforce its intellectual property rights on trademarks, copyright and patents.

Along with CBP, the Bureau of Industry and Security (BIS), an agency of the US Department of Commerce, monitors and regulates the import and export of goods across US borders. BIS manages and enforces export control and treaty compliance, including those related to anti-boycott laws under Export Administration Act provisions. BIS makes unofficial electronic Export Administration Regulations (EAR) files accessible on its website, while the FR provides the official text. BIS makes boycott guidelines (43 FR 3454, 44 FR 66272, 49 FR 18061 and 52 FR 2511) accessible on its website. In addition, foreign boycott requests or acts of compliance with such boycotts that do not align with US policy, are reportable on the BIS website.10

US Government Agencies

This section features government agency websites offering additional healthcare product regulatory information. A regulatory professional’s decision-making process is shaped by several federal agency regulations and guidelines. This chapter will not go into detail about all these governmental bodies, but Table 41-1 provides the websites where further information can be gained about these agencies.

Table 41-1. Agencies, Organizations, Institutes, Centers and Offices Associated With Healthcare Product Regulation

Organization

Website

Subject Coverage

US Consumer Product Safety Commission (CPSC)

www.cpsc.gov

Safety Education, Recalls, Poisoning, Packaging, Labeling, Drugs, Children’s Products

www.cpsc.gov/en/Regulations-Laws--Standards

Regulations, Laws, Bans, Guidances, Standards, Federal Register Notices

US Environmental Protection Agency (EPA)

www.epa.gov

Environment Health, Public Health, Chemicals, Air Pollutants, Medical Waste

US Department of Health and Human Services (DHHS)

www.hhs.gov

Public Health, Food Safety, Drugs, Medical Devices, Biologics, Blood and Vaccines Devices, Cosmetics, Radiation Emitting Products, Combination Products, Grants and Funding, Research, Health Insurance

Assistant Secretary for Preparedness and Response (ASPR)

www.phe.gov

Public Health and Medical Disasters and Emergencies

Administration of Community Living (ACL)

www.acl.gov

Aging and Disability Population

Agency for Healthcare Research and Quality (AHRQ)

www.ahrq.gov

Research and Resources on Outcomes, Cost, Safety, Access and Quality of Healthcare

Centers for Disease Control (CDC)

www.cdc.gov

Disease Control and Prevention

National Institute for Occupational Safety and Health (NIOSH)

www.cdc.gov/niosh

Prevention of Workplace Illness and Injury

Agency for Toxic Substances and Disease Registry (ATSDR)

www.atsdr.cdc.gov

Harmful Exposures and Diseases Related to Toxic Substances

Centers for Medicare & Medicaid Services (CMS)

www.cms.gov

Medicare, Medicaid and Children’s Health Insurance Program (CHIP) coverage

US Food and Drug Administration (FDA)

www.fda.gov

Public Health, Regulations, Food, Drugs, Medical Devices, Biologics, Vaccines, Tissue and Tissue Products, Blood and Blood Components, Cosmetics, Animal and Veterinary Products

Center for Biologics Evaluation and Research (CBER)

www.fda.gov/BiologicsBloodVaccines

Vaccines, Blood and Biologics

Center for Drug Evaluation and Research (CDER)

www.fda.gov/Drugs

Drugs

Center for Devices and Radiological Health (CDRH)

www.fda.gov/MedicalDevices

Medical Devices

Center for Food Safety and Applied Nutrition (CFSAN)

www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN

Food and Cosmetics Safety

Center for Veterinary Medicine (CVM)

www.fda.gov/animalveterinary

Animal and Veterinary Products

Office of Combination Products (OCP)

www.fda.gov/CombinationProducts

Combination Products

Freedom of Information (FOI) Electronic Reading Room

www.fda.gov/RegulatoryInformation/foi/ElectronicReadingRoom

Frequently Requested FDA Documents

Information for the FDA-Regulatory Industry

www.fda.gov/forindustry

Information for Companies

Health Resources and Services Administration (HRSA)

www.hrsa.gov

Healthcare Access

Indian Health Services (IHS)

www.ihs.gov

Public Health of Federally Recognized American Indians and Alaska Natives

National Institutes of Health (NIH)

www.nih.gov

Biomedical and Clinical Research Resources

Substance Abuse & Mental Health Services Administration (SAMHSA)

www.samhsa.gov

Behavioral Health: Substance Abuse and Mental Illness

US Small Business Association (SBA)

www.sba.gov

Congressional Advocacy, Federal Procurement, Training and Financing

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

www.ich.org

Drugs and Biologics

International Medical Device Regulators Forum (IMDRF) (formerly Global Harmonization Task Force (GHTF))

www.imdrf.org

Medical Devices

www.imdrf.org/documents/documents.asp

Archived Documents

World Health Organization (WHO)

www.who.int/en

Public Health, Drugs, Medical Devices, Biologics, Vaccines

www.who.int/library/databases

Medical Dictionary for Regulatory Activities (MedDRA)

www.meddra.org

Standardization of Medical Terminology for Adverse Events and Medication Errors Coding

Occupational Safety & Health Administration (OSHA)

www.osha.gov

Safety and Health in Workplace

Federal Trade Commission (FTC)

www.ftc.gov

Prevention of Fraud, Deception, and Unfair/Anticompetitive Business Practices

US Nuclear Regulatory Commission (NRC)

www.nrc.gov

Radioactive Materials

US Patent and Trademark Office (PTO)

www.uspto.gov

Granting Patents, Registering Trademarks, Intellectual Property Law and Policy

Note: Website URLs are current at time of publication.

The US Department of Health and Human Services (DHHS) is the US federal agency whose mission is to protect the health of all US citizens and provide essential human services. The office of the secretary and its subdivisions carry out DHHS’ initiatives while 11 operating agencies perform a broad range of tasks and services, from conducting research and ensuring food and drug safety to funding grants and programs and managing health insurance. The specific operating agencies include: the Administration for Children and Families (ACF), Administration on Community Living (ACL), Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Center for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (HIS), National Institutes of Health (NIH) and Substance Abuse and Mental Health Services Administration (SAMHSA). Further discussion focuses on FDA.

FDA consists of nine centers and offices, each of which provides a website offering detailed regulatory information. The Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) homepages all offer product-specific topical coverage, spotlighted center links, recalls and alerts, approvals and clearances, news and announcements, resources targeting industry, consumers and healthcare professionals, links to program area coverage, a search box and contact information. The FDA website also provides several convenient listings, which include but are not limited to the Humanitarian Device Exemptions Listing, FDA Debarment List (Drug Product Applications) and Clinical Investigators—Disqualification Proceedings.

A few other particularly helpful resources found on FDA’s website are the Office of Regulatory Affairs (ORA) and the Office of Combination Products (OCP) pages. OCP’s website is designed to assist users in classifying their products. Consequently, this page provides an overview of OCP, a section with links to further information, including the combination products page, guidance documents, information pertaining to the request for designation process, performance reports and contact information. The ORA page features a spotlight section, ORA news, links to resources and requested documents, recalls and alerts and a link to the ORA Freedom of Information Act (FOIA) electronic reading room. The FOI page contains links to frequently asked questions; how to make an FOIA request; FOIA fees; online payments; an electronic reading room; annual reports; the Privacy Act; reference materials; and contacts and links to other FOIA requester centers.

As an added resource, FDA hosts training modules on its website on CBER, CDRH, guidances, nonclinical studies and clinical investigations to foster transparency between FDA and academia, industry and clinical investigators, and to promote public health by ensuring the safety and quality of regulated medical products.11 A subset of these learning tools is offered in French and Spanish to service the international audience. In addition, FDA periodically hosts online webinars with senior FDA officials speaking on specific topics and attendees given the opportunity to ask questions. Recent topics have included drug shortages, over-the-counter (OTC) medicines and drug trial snapshots.12

The US Consumer Product Safety Commission (CPSC) is another agency deeply impacting product development decisions. CPSC’s primary mission is to protect the public from unreasonable risks of injury or death from a broad range of consumer products. For example, its poison prevention packaging standards and testing procedures, as well as its child-resistant and senior-friendly packaging guidelines, determine how OTC and prescription drugs and physician samples must be packaged.

Last, the US Federal Trade Commission (FTC) addresses issues related to enforcing appropriate business competition and monitoring anticompetitive practices. FTC’s Bureau of Consumer Protection is specifically responsible for handling fraudulent and dishonest consumer protection activities, which encompass advertising and e-commerce oversight. Advertising and consumer safety also are key priorities for healthcare product regulatory professionals.

Table 41-2. Publisher Resources

Publisher

Website

Resources

International Electrotechnical Commission (IEC)

www.iec.ch

Newsletters, News Alerts, Standards, CDs

AdvaMed

www.advamed.org

News Alerts**

American National Standards Institute (ANSI)

www.ansi.org

Standards, Newsletters, Articles*

American Society for Quality (ASQ Quality Press)

www.asq.org

Journals, Books, Standards

American Society for Testing and Materials (ASTM)

www.astm.org

Standards, Journals, Research Reports, Symposia Papers, Proceedings, Manuals

Association for the Advancement of Medical Instrumentation (AAMI)

www.aami.org

Newsletters, Journals, CDs, Standards

Association of Clinical Research Professionals (ACRP)

www.acrpnet.org

Newsletters, Journals, Reports, White Papers, Directories*

Barnett International

www.barnettinternational.com

Books, Reference Manuals, Compendiums

Bentham Science

www.benthamscience.com

Books, Journals

Bureau of National Affairs (BNA)

www.bna.com/books

News Alerts, Newsletters*

CenterWatch

www.centerwatch.com

Newsletters, Books, Report, Guides, Data Libraries

CRC Online Press (Taylor & Francis Group)

www.crcpress.com

Books, Journals

Drug Information Association (DIA)

www.diahome.org

Newsletters, Journals, White Papers, Directories*

Elsevier Business Intelligence

pharmamedtechbi.com

Newsletters

FDAnews

www.fdanews.com

Newsletters, Books, Reports, White Papers, CDs*

Ferdic Inc.

www.fdareview.com

Newsletters

FierceMarkets

www.fiercemarkets.com

Newsletters

Food and Drug Law Institute (FDLI)

www.fdli.org

Newsletters, Books, Journals, White Papers, CDs*

Global Regulatory Press

globalregulatorypress.com

Journals

GMP Publications

www.gmppublications.com

Books, Handbooks, Manuals

Government Printing Office (GPO)

bookstore.gpo.gov

Newsletters, Books, Journals, Handbooks, Manuals, Guides*

Infinata

www.infinata.com

Newsletters, White Papers, Reports**

Institute for Electrical and Electronics Engineers (IEEE)

www.ieee.org

Standards, Books, Journals, Conference Publications

International Organization for Standardization (ISO)

www.iso.org

Journals, Standards, Handbooks, CDs

John Wiley & Sons

www.wiley.com/WileyCDA

Books, Journals

Majors.com

www.majors.com

Books

Medical Device Manufacturers Association (MDMA)

www.medicaldevices.org

News Alerts, Newsletters, Reports, White Papers, Directories*

Medtech Insight

www.medtechinsight.com

Newsletters, Reports

OMICS Group International

omicsgroup.org/journals/pharmaceutical-regulatory-affairs-open-access.php

Journals**

Outcomes LLC

www.outcomes-marketing.com

Newsletters**

Paternal Drug Association (PDA)

www.pda.org

Books, Journals, Directories*

Pharmaceutical-technology.com (Net Resources International)

www.pharmaceutical-technology.com

Newsletters, White Papers, Directories**

Regulatory Affairs Professionals Society (RAPS)

www.raps.org

Newsletters, Books, Guidances, Handbooks

SmartBrief

www.smartbrief.com

Newsletters**

Society of Clinical Research Associates (SoCRA)

www.socra.org

Newsletters, Journals, Manuals

Springer

www.springer.com

Books, Handbooks, Journals

The Organisation for Professionals in Regulatory Affairs (TOPRA)

www.topra.org

Newsletters

Thompson Publishers

www.thompson.com

Newsletters, Books, Reports, CDs

Thomson-Reuters (Life Sciences)

lifesciences.thomsonreuters.com

Articles, Reports, Databases*

Tradepub.com

www.tradepub.com

Books, Newsletters, White Papers**

UBM Canon

ubmcanon.com

News Alerts, Newsletters, Directories**

United States Pharmacopeia (USP)

www.usp.org

Books, Compendiums, Standards*

Wolters Kluwer (Law & Business; Health)

www.wolterskluwerlb.com/health

White Papers, Databases*

*Resource may be fee-based or free. **Resource is free.
The absence of any asterisk indicates that the resource is fee-based. However, costs for members may differ.
Note: Website URLs are current at time of publication.

Online Commercial and Government Databases

An integral component of a regulatory professional’s work is to stay informed about the latest regulatory and legislative developments. The resources reviewed in this section highlight noteworthy governmental database tools to support these monitoring and surveillance responsibilities. Numerous commercial, fee-based, web-based databases and free, federal, web-based databases are available to support the regulatory professional’s legislative tracking and regulatory analysis responsibilities.

Federal Government Databases—Agency Resources

Many federal agencies have built their own specialized databases to monitor specific regulatory issues and provide public access to biomedical, clinical and other useful government resources. The beginning of this chapter discusses databases housing US Governing Law (e.g., THOMAS, CROSS and FDsys). Further review will highlight repositories useful for manufacturer and device registrations, submission preparation and postmarket surveillance. This section focuses primarily on the databases created within FDA’s centers.

CDER and CDRH have developed the largest number of database systems, with some overlap between CDER and CBER. CVM and CFSAN also have developed some unique databases. Due to chapter length constraints, however, this summary will review only selected center databases. A comprehensive list of all the agency’s databases and corresponding website addresses is provided in Table 41-3.

Three of CDER’s most heavily searched databases focus on drug product approvals: the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) database, which lists drugs approved on the basis of safety and effectiveness; the National Drug Code Directory, a database of marketed prescription drugs listed by universal product identifiers; and the Drugs@FDA database, a searchable catalog of brand-name and generic prescription and OTC human drugs and biological therapeutic products approved since 1939. Drug manufacturing firms are required to register their sites with Drugs@FDA and re-register annually at the Drug Establishments Current Registration Site (DECRS) database. As a self-identification and Drug Establishment Registration and Drug Listing requirement, FDA requires human generic drug facilities to obtain Data Universal Numbering System (D-U-N-S) numbers for the facility or site and in some cases the registrant owner of the facility or site. Since 1963, D-U-N-S numbers, established by Dun & Bradstreet (D&B), have been used as business identifier.13 The D-U-N-S number uniquely identifies the registrant and each physical location of the business’s facility or site to FDA. Requests are made online. Typically, requests for new D-U-N-S numbers are processed in 20 business days, although a business can expedite the otherwise free service process for a nominal service fee. D&B hosts a public database for searching a company’s D-U-N-S number.14

CDER’s two clinically oriented databases are the Bioresearch Monitoring Information System, which identifies personnel engaged in Investigational New Drug (IND) studies; and the Clinical Investigator Inspection List Database, which contains data relevant to IND studies gathered by clinical investigator inspections.

CDER and CBER share the responsibility for reviewing postmarket safety reports submitted to the FDA Adverse Event Reporting System (FAERS), a database containing voluntarily submitted reports on approved drugs or therapeutic biologics products. CBER’s other database systems include one for storing incoming Biological Product Deviation Reports and a Vaccine Adverse Event Reporting System (VAERS). Like the FAERS database, VAERS is based on a cooperative agency program between CBER and CDC to address vaccine safety.

CVM’s Animal Drugs@FDA is comparable to CDER’s Drugs@FDA and CDRH’s 510(k) and PMA databases. This database allows users to search for approved animal drug products, suitability petitions, sponsors, the Green Book, CFR, FR, patents and exclusivity. In addition, FDA maintains its own Warning Letter database through its FOI office. The Warning Letter collection covers documents issued from November 1996 to present. The database can be searched by company, subject, issuing office or date.

CDRH has built and maintains more than 20 databases to monitor medical devices and radiological products. Its 510(k) Premarket Notification (PMN) database and its Premarket Approval (PMA) database are critical tools for device regulatory professionals. CDRH also has developed two adverse event reporting systems similar to CDER’s FAERS database: the MAUDE (Manufacturer and User Facility Device Experience) database and the Medical Device Reporting (MDR) (formerly CDRH’s Device Experience Network) database. MAUDE presents voluntarily submitted user facility medical device adverse event reports since 1991, distributor reports since 1993 and manufacturer reports since 1996. The MDR database consists of reports on devices that may have malfunctioned or caused a death or serious injury from 1984–96, when it was replaced by MAUDE.

Also, CDRH provides an integrated database offering a total lifecycle summary of a selected medical device. The Total Product Life Cycle (TPLC) database requires the user to input the product code, regulation number or common device name to receive a summary of PMNs and/or PMAs, device problems and recalls by year, recall class and device class.

Other noteworthy CDRH databases include the Clinical Laboratory Improvement Amendments (CLIA) database, which represents commercially marketed FDA- and CDC-categorized in vitro diagnostic test systems; and the Establishment Registration database, which comprises domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly or processing of medical devices intended for human use and commercial distribution.

Recently, in collaboration with the National Library of Medicine (NLM), FDA released a web-based database, AccessGUDID, making medical device identification information publicly available. With the transition to unique device identifiers (UDI) by device labelers, the database will continue to populate with downloadable Global Unique Device Identifier Database (GUDID) data, which correspond to unique identifier content from the medical device label. Establishing UDI introduced Global Medical Device Nomenclature (GMDN), an internationally recognized identifier, as a requirement for labeling by FDA. The GMDN codes serve as a numerical identifier corresponding to a descriptor for a common device type. GMDN codes are purchased from the GMDN Agency, the entity that manages the categorization and creation of new GMDN terms.

In addition to the regulatory information available through FDA’s databases, regulatory professionals requiring biomedical research can access PubMed, NLM’s biomedical database, which includes more than 24 million citations from MEDLINE and other life science journals dating back to 1948. NLM also produces TOXNET, the toxicology data network, which consists of databases on toxicology, hazardous chemicals, environmental health and toxic releases. For molecular biology information, NLM’s National Center for Biotechnology Information (NCBI) offers a comprehensive resource. Established in 1988, NCBI has created numerous public databases covering genetic sequencing and molecular processes affecting human health and disease and has developed software tools for analyzing genome data. Finally, the NIH’s ClinicalTrials.gov site contains current information identifying federally and privately supported clinical trials for a range of diseases and conditions. The database includes 193,756 trials sponsored by NIH, other federal agencies and private industry conducted in all 50 states and 190 countries.

Another CDRH database is the Advisory Committee/Panel Meetings database, which contains both information about upcoming meetings and historical information with links to summaries and/or transcripts of recent past meetings.

A few additional recommended federal databases are RegInfo.gov, USA.gov and Regulations.gov. The Office of Management and Budget (OMB) and the General Services Administration (GSA), jointly produce RegInfo.gov. This website contains a catalog searchable by government agency to locate all the regulatory reviews conducted by OMB’s Office of Information and Regulatory Affairs (OIRA). It also has a catalog of GSA’s Regulatory Information Service Center’s (RISC) semi-annually published Unified Agenda of Federal Regulatory and Deregulatory Actions dating back to late 1995. The Regulatory Plan is part of the fall edition of the Unified Agenda. The Regulatory Plan serves as a defining statement of the administration’s regulatory and deregulatory policies and priorities, while the Unified Agenda provides information about regulations the government is considering or reviewing. USA.gov is the government’s official portal to federal agency websites and information. This website is the product of an interagency initiative administered by the Government Accountability Office’s (GAO) Office of Citizen Services and Communications. It provides a centralized database to locate information on US local, state and federal government agency websites. Regulations.gov is another valuable tool for locating government agency regulations, rulemakings or notices, and also is useful for finding, submitting and obtaining public comments on proposed FR regulations. A comment can be submitted directly via the website by accessing documents still open for public comment.

Table 41-3 provides websites for federal databases useful in reviewing the following additional topics:

  • Warning Letters and recalls
  • adverse event reporting
  • consumer product injury surveillance
  • product and substance registration
  • site registration and inspections
  • guidances, consensus standards and drug recommendations
  • product classification
  • orphan drug designations
  • postmarket requirements and studies
  • nonclinical study recommendations
  • clinical trials
  • export certificates and import communications
  • labeling: supplements, pediatrics and drugs
  • Medicare coverage database and drug shortages
  • supplement and inactive ingredients
  • patents
Table 41-3. Databases for Healthcare
Product Regulatory-Related Intelligence

Database

Website

Subject Coverage

  

GOVERNMENT:

  

CPSC/Consumer Product Safety Information Database

www.saferproducts.gov

Searchable reports and recalls related to consumer products

  

CPSC/National Electronic Injury Surveillance System (NEISS)

www.cpsc.gov/en/Research--Statistics/NEISS-Injury-Data

US sample of emergency room injury reports for consumer products

  

Federal Recalls

www.recalls.gov

Compilation of federal recalls: environmental, food, medicinal, cosmetic and consumer products

  

CMS/National and Local Coverage Determinations (NCD/LCD)

www.cms.gov/medicare-coverage-database/
indexes/national-and-local-indexes.aspx

Medicare coverage

  

CMS/Open Payments

www.cms.gov/openpayments

Financial relationships between manufacturers/group purchasing organizations (GPOs) and hospitals/physicians

  

USA.gov

www.usa.gov

Federal information and services portal

  

www.usa.gov/Topics/Reference-Shelf/forms.shtml

Federal forms and applications

  

NIH/NLM PubMed

www.pubmed.gov

Bibliographic database of biomedical and life science journal articles at NIH/NLM

  

www.ncbi.nlm.nih.gov/pubmed

  

Regulations.gov

www.regulations.gov

Public comments, agency regulatory agendas, federal regulations, federal notices and federal adjudications

  

resources.regulations.gov/public/component/main

  

GSA/OIRA/OMB Reginfo.gov

www.reginfo.gov/public/do/eAgendaSimpleSearch

Federal regulatory agendas/plans and regulatory/deregulatory actions

  

GPO Access: Federal Register and Code of Federal Regulations (CFR)

www.gpo.gov/fdsys

Legislative intelligence

  

Congress.gov

www.congress.gov

Federal legislative information: bills, records and reports

  

FDA Acronyms and Abbreviations

www.accessdata.fda.gov/scripts/cder/acronyms

General information

  

FDA Guidance Documents

www.fda.gov/RegulatoryInformation/Guidances

Guidance on FDA-regulated products

  

FDA/Inspections Database

www.accessdata.fda.gov/scripts/inspsearch

Compliance status of firms marketing FDA-regulated products

  

FDA/Warning Letter Archive

www.fda.gov/ICECI/EnforcementActions/WarningLetters

Warning letters

  

FDA/Medical Product Safety Network (MedSun)

www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/searchReport.cfm

Device regulatory intelligence: adverse event reporting

  

NIH/ClinicalTrials.gov

clinicaltrials.gov

Publicly and privately supported global clinical studies

  

National Cancer Institute (NCI) Clinical Trials

www.cancer.gov/clinicaltrials

NCI-sponsored clinical trial studies

  

NIH/ClinRegs

clinregs.niaid.nih.gov

Country-specific clinical research regulatory information

  

FDA/Global Unique Device Identification Database (GUDID)

gudid.fda.gov/gudid

FDA-regulated devices with unique identifier (not yet searchable)

  

accessgudid.nlm.nih.gov

Public-access to GUDID (beta version)

  

FDA/Label Repository

labels.fda.gov

Drug regulatory intelligence: drug labels and other drug-specific information

  

FDA/Pediatric Labeling Information Database

www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase

Pediatric labeling information

  

FDA/Import Trade Auxiliary Communications System (ITACS)

itacs.fda.gov/app/welcomeToITACS.jsf

Import tracking

  

USPTO/Patent Database

appft.uspto.gov/netahtml/PTO

Patent databases

  

USPTO/Global Patent Search Network

gpsn.uspto.gov

International patent collections

  

USPTO/Patent Application Information Retrieval

portal.uspto.gov/pair/PublicPair

Issued patents and status of published patent applications

  

CBP/Intellectual Property Rights Search

www.dhs.gov/intellectual-property-rights-search

Intellectual property rights

  

FDA/Device Registration & Listing Module

www.access.fda.gov

FDA Unified Registration and Listing System (FURLS)

  

FDA/Biologics Export Certification Application & Tracking System

  

FDA/CDRH Export Certification Application & Tracking System

  

FDA/CVM Approved Animal Drug Products

www.accessdata.fda.gov/scripts/animaldrugsatfda

Drug regulatory intelligence: approved animal products

  

www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/

Green Book: approved animal drug products

  

FDA/CVM Veterinary Recalls

www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals

Drug regulatory intelligence: recalls

  

NIH and US Department of Agriculture (USDA)/ Dietary Supplement Ingredient Database

dietarysupplementdatabase.usda.nih.gov

Dietary Supplement Ingredient Database (DSID)

  

NIH and NLM/Dietary Supplement Label Database

www.dsld.nlm.nih.gov/dsld

Sample dietary supplement product labels

  

FDA/CDRH Product Classification

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

Device regulatory intelligence: product codes and device classification

  

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm

Device regulatory intelligence: de novo classification orders

  

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm

Device regulatory intelligence: radiation-emitting electronic product codes

  

FDA/CDRH Premarket Clearances and Approvals

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

Device regulatory intelligence: PMA

  

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pmamemos.cfm

Device regulatory intelligence: PMA summary review memos

  

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Device regulatory intelligence: 510(k)

  

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm

Device regulatory intelligence: approved Humanitarian Device Exemptions (HDEs)

  

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm

Device regulatory intelligence: cleared or approved OTC in vitro diagnostic products

  

FDA/CDRH Establishment Registration & Listing

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Device regulatory intelligence: medical devices and establishments registered with FDA

  

FDA/CDRH Establishment Inspections

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/inspect.cfm

Device regulatory intelligence: establishment inspections

  

FDA/CDRH Recognized Consensus Standards

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

Device regulatory intelligence: federally recognized national and international medical device standards

  

FDA/CDER Postmarket Requirements and Commitments

www.accessdata.fda.gov/scripts/cder/pmc

Drug/Biologic regulatory intelligence: postmarket requirements, studies and clinical trials for approved products

  

FDA/CDRH 522 Postmarket Surveillance Studies

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm

Device regulatory intelligence: studies mandated under Section 522 of the FD&C Act

  

FDA/In Vitro Diagnostic Device Recalls

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/IVDRes.cfm

Device regulatory intelligence: IVD recalls

  

FDA/CDRH Corrective Actions and Recalls

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD_RH/rh_res.cfm

Device regulatory intelligence: radiation-emitting electronic products corrective actions

  

FDA/Medical Device Recalls

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

Device regulatory intelligence: medical device recalls

  

FDA/CDRH Medical Device Reporting (MDR)

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.CFM

Device regulatory intelligence: device-related adverse events and product problems

  

FDA/MedWatch

www.fda.gov/Safety/MedWatch

Safety Information and Adverse Event Reporting Program

  

FDA/CDRH Manufacturer and User Facility Device Experience (MAUDE)

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Device regulatory intelligence: monitoring for device-associated deaths, serious injuries and/or malfunctions

  

FDA/CDRH Clinical Laboratory Improvement Amendments (CLIA)

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

Device regulatory intelligence: certified clinical laboratory diagnostic test

  

FDA/CDRH CLIA-Waived Analytes

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Device regulatory intelligence: waived clinical laboratory diagnostic test

  

FDA/CDRH Meetings/Panels

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/search.cfm

Device regulatory intelligence: Advisory Committee Meeting materials

  

FDA Meetings, Workshops and Conferences

www.fda.gov/NewsEvents/MeetingsConferencesWorkshops

Calendar of events and meeting materials

  

FDA/CDRH Total Product Life Cycle (TPLC)

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm

Device regulatory intelligence: PMA, 510(k), adverse events, and recalls

  

FDA/CDER FDA-Recommended Dissolution Methods

www.accessdata.fda.gov/scripts/cder/dissolution

Drug regulatory intelligence: methods recommended by the Division of Bioequivalence, Office of Generic Drugs

  

FDA/CDER Drugs@FDA Database

www.accessdata.fda.gov/scripts/cder/drugsatfda

Drug regulatory intelligence: approved products

  

FDA/CDER National Drug Code Directory

www.accessdata.fda.gov/scripts/cder/ndc

Drug regulatory intelligence: all drugs available for commercial distribution

  

FDA/CDER Drug Establishments Current Registration Site (DECRS) Database

www.accessdata.fda.gov/scripts/cder/drls

Drug regulatory intelligence: establishments registered with FDA

  

FDA/CDER Bioresearch Monitoring Information System (BMIS)

www.accessdata.fda.gov/scripts/cder/bmis

Biologics/Drug regulatory intelligence: responsible parties involved in Investigational New Drug (IND) studies

  

FDA/CDER Clinical Investigator Inspection List (CLIIL)

www.accessdata.fda.gov/scripts/cder/cliil/index.cfm

Device regulatory intelligence: clinical investigators involved with IND studies

  

FDA/CDER Adverse Event Reporting System (FAERS)

www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Surveillance/AdverseDrugEffects/ucm082193.htm

Biologics/Device regulatory intelligence: adverse event and medication error reports

  

NIH/NLM Toxicology Data Network (TOXNET)

www.toxnet.nlm.nih.gov

Scientific and regulatory intelligence on hazardous drugs and other chemicals

  

FDA/CDER Inactive Ingredients Database

www.accessdata.fda.gov/scripts/cder/iig/index.cfm

Drug regulatory intelligence: inactive ingredients for approved products

  

FDA/Substance Registration System

fdasis.nlm.nih.gov/srs/srs.jsp

Unique Ingredient Identifier (UNII) repository for FDA-regulated products

  

FDA/CDER Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Database

www.accessdata.fda.gov/scripts/cder/ob

Drug regulatory intelligence: approved products

  

FDA/Orphan Drug Designations and Approvals

www.accessdata.fda.gov/scripts/opdlisting/oopd

Drug regulatory intelligence: designations and approvals

  

FDA/Reported Drug Shortages and Discontinuations

www.accessdata.fda.gov/scripts/drugshortages

Drug regulatory intelligence: current and resolved drug shortages and discontinuations reported to FDA

  

FDA/Product-Specific Recommendations for Generic Drugs

www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm075207.htm

Bioequivalence recommendations for specific products arranged by active ingredient

  

FDA/CBER Vaccine Adverse Event Reporting System (VAERS)

vaers.hhs.gov/index

Drug regulatory intelligence: reports (unverified) of adverse events with US-licensed vaccines

  

wonder.cdc.gov/vaers.html

  

medalerts.org/

  

FDA/Human Cell and Tissue Establishment Registration-Query

www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss

Registered Human Cell and Tissue Establishments

  

FDA/Blood Establishment Registration-Query

www.accessdata.fda.gov/scripts/cber/cfappspub

Registered Blood Establishments

  

FDA/Electronic Biological Product Deviation Reporting (eBPDR) System

www.accessdata.fda.gov/scripts/cber/CFApps

Events for biologics, blood (or components), human cell, tissue and cellular and tissue-based product (HCT/P)

  

NON-GOVERNMENTAL:

  

WHO/ISRCTN Registry

www.isrctn.com/search?q=

Clinical trial registry (proposed, ongoing or completed studies)

  
GOVERNMENT:  

GovTrack.us

www.govtrack.us

Legislative intelligence on bills and congressional voting

  

Global Medical Device Nomenclature (GMDN) Agency

www.gmdnagency.com

Medical device identifiers

  

Note: Website URLs are current at time of publication.

Elsevier’s PharmaPendium database, by comparison, provides drug safety data on FDA-approved drugs. This online resource affords researchers searchable access using the Medical Dictionary for Regulatory Activities (MEDRA) search terminology. It also incorporates animal and human study data from FAERS, preclinical and clinical studies, and postmarket data.15 Regulatory professionals can use this database to obtain pharmacovigilance data to evaluate projected risks from PharmaPendium’s FDA database.

Databases with Global Regulatory Coverage

Databases providing global coverage of country-specific regulations and guidelines also play an essential role in the regulatory professional’s capability to monitor legislative developments, conduct regulatory analyses and understand compliance requirements for all phases of the drug, biologic and device product development lifecycles. These are invaluable tools when used in conjunction with other sources of regulatory expertise, from networking with colleagues to contacting consultants and/or communicating directly with government agency authorities. This section discusses several databases offering international regulatory information.

Publically launched in September 2014, NIAID’s ClinRegs is designed to help clinical researchers navigate country-specific, regulatory information as they plan and implement clinical trials. ClinRegs, an online database was developed by NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The site is a central resource providing the research community with up-to-date regulatory information for multiple countries. Organized by country and topic areas, the site also allows users to compare countries’ requirements side by side. Topic areas the website addresses include: clinical trial lifecycle, Competent Authority oversight, Ethics Committee oversight, informed consent, investigational products, specimens and sponsorship. ClinRegs currently includes clinical research regulatory information summarized in English for Brazil, China, India, Kenya, Liberia, Malawi, Peru, South Africa, Tanzania, Thailand, Uganda, Vietnam, Liberia, Sierra Leone, Guinea, the UK and US.16

The Tarius Regulatory Database, a fee-based subscription database service, enables regulatory professionals to stay informed about the latest legislative developments worldwide and to interpret regulations and guidelines applicable to global healthcare products. Tarius offers three product types: customized regulatory web portal, SAC Tracker and Medical Device ‘Lite’. The customized database solution prescreens data from multiple global government and legislative websites based on product type and/or country, according to searches defined by a particular company or individual. SAC Tracker provides access to FDA Advisory Committees’ scientific and technical updates provided by CDER, CBER and the Office of the Commissioner. Tarius provides analyses, summaries and voting results by way of newsletter or web portal. Medical Device ‘Lite’ includes continuously updated reference documents compiled from US and EU regulatory authorities and key international regulatory bodies (e.g., IMDRF and ISO).17

Thomson Reuters Cortellis’ Intelligent Regulatory Database (IDRAC) is another fee-based global regulatory intelligence database of regulatory, legal and scientific information accessed by professionals who develop and register human drug and biologics products.18 As is true of Tarius, IDRAC frequently updates its documents and provides expert analyses on key regulatory topics for more than 40 countries. Wolters Kluwer’s MediRegs is also a provider of healthcare research products and software solutions for regulatory professionals.19 The database includes a Pharmaceutical and Device Regulation Suite offering consolidated federal resources.

Clinical trial surveillance information also is accessible through Informa PLC’s TrialTrove. This database contains a comprehensive repository of global ongoing clinical trials information. Clinical and regulatory professionals have access to global trial information organized by more than 180 disease groups through analyst monitoring of more than 30,000 data sources.20 Like the Pipeline database product, TrialTrove offers users a research support service with direct access to Citeline analysts for no extra charge. Informa PLC’s Pharmaprojects database also serves as a valuable source of pharmaceutical intelligence. This tool tracks more than 60,000 drugs in active development with a drug, company and therapy profile for each.21 The drug profile contains product data, including therapies and indications by phase; originator and licensees; chemical data and structure; clinical trials; pharmacologies; country information; licensing opportunities and more.

Industry and International Standards

The International Organization for Standardization (ISO) is a key nongovernmental standards-producing organization, comprising a network of national standards institutes representing 163 countries, 3,368 technical bodies and a coordinating Central Secretariat in Geneva, Switzerland. ISO’s catalog comprises more than 19,500 published international standards related to quality management, risk and many other drug and device lifecycle facets.22 The American Society of Testing and Materials (ASTM) is a similar standards organization that produces Special Technical Publications, compilations, manuals, monographs, journals and handbooks on regulatory topics. The standards’ publications focusing on healthcare regulatory issues may be found through a search of the following terms:

  • biological
  • biotechnology
  • clinical
  • pharmaceutical
  • medical device
  • medical instrumentation
  • quality management
  • regulatory

In the same manner, the United States Pharmacopeia (USP), an official public standards-setting authority for prescription, OTC medicines and US-manufactured healthcare products, develops documentary and quality reference standards. Its key publications include the USP–National Formulary (NF), the USP Dietary Supplements Compendium (DSC) and the Food Chemical Codex (FCC). The USP–NF contains public pharmacopeial standards for medicines, dosage forms, drug substances, excipients, medical devices and dietary supplements. Similarly, the DSC offers standards and scientific information related to the development, manufacturing and testing of dietary supplements. The FCC provides standards for the identification and purity of food ingredients. The DSC is updated every three years, the FCC is published every two years and revision bulletins for the USP-NF are posted at the start of each month.23

Another valuable standards resource for regulatory professionals is IEEE, formerly the Institute of Electrical and Electronics Engineers, which develops and publishes conference proceedings, training materials, standards and publications central to regulatory research. It is the leading global professional association for the advancement of technology and the authority on biomedical engineering and medical devices. Similarly, the International Electrotechnical Commission (IEC) develops and publishes standards for electrical and electronic technologies.

Historically, FDA has joined forces with several standards organizations to improve the safety, interoperability and implementation of standards, e.g., the Association for the Advancement of Medical Instrumentation (AAMI) and the National Institute of Standards and Technology (NIST). Note FDA’s enforced performance standards are not limited to the aforementioned organizations; the agency relies on a growing list of organizations, including the American National Standards Institute (ANSI), the Clinical Laboratory Standards Institute and the Underwriters Laboratories Inc., among others, to ensure regulated products’ safety and quality.

Global Harmonized Guidelines

Although this chapter focuses on US regulatory resources, a few global organizations are too important to overlook, given the critical US role within each of these groups in developing global guidelines. The International Conference on Harmonisation (ICH) is one of these global bodies. ICH brings together EU, US and Japanese regulatory bodies and pharmaceutical industry experts in the three regions to discuss scientific and technical aspects of product registration. ICH’s safety, efficacy, quality and multidisciplinary guidelines are indispensable to pharmaceutical and biologics regulatory professionals (and medical device professionals with Q9 Quality Risk Management and guidelines on Clinical Trials and Human Subject Protection) in evaluating proposed products and ensuring regulatory compliance. ICH representatives include drug regulatory authorities from Australia, Brazil, China, Chinese Taipei, India, Republic of Korea, Russia, Singapore, the EU and the US, as well as the World Health Organization (WHO), which serves as an official observer. Six Regional Harmonisation Initiatives (RHIs) also are active participants in ICH meetings: Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), East African Community (EAC), Gulf Cooperation Countries (GCC), Pan American Network on Drug Regulatory Harmonization (PANDRH) and South African Development Community (SADC). Representatives from the EU, Japan, Canada, the US, WHO, the Pharmaceutical Research and Manufacturers of America (PhRMA) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) serve on the ICH steering committee.24 Since 1958, PhRMA has represented American biopharmaceutical research companies’ interests in the alignment between medical research and policy, as they relate to addressing patient needs.25

US regulatory representatives also participate actively in the International Medical Device Regulators Forum (IMDRF), successor to the Global Harmonization Task Force on Medical Devices (GHTF). IMDRF is composed of medical device regulators from Australia, Brazil, Canada, China, Japan, Russia, the EU and the US, and is building the GHTF foundation. The World Health Organization (WHO) and APEC Life Sciences Innovation Forum (LSIF) Regulatory Harmonization Steering Committee are official observers to IMDRF.26 The original GHTF documents embody harmonized regulatory practices for medical device safety, effectiveness, performance and quality. Device regulatory professionals can review these documents when evaluating device conformity assessment, quality management systems and postmarket surveillance issues surrounding their device products.

WHO provides worldwide leadership on health matters, shapes the health research agenda and sets United Nations’ norms and standards. The US is an active WHO participant, particularly in the Essential Medicines and Pharmaceutical Policies Department, which develops, implements and monitors national medicines’ policies and guidelines. It also participates in WHO’s biologicals program, the goal of which is to ensure national regulatory authorities implement effective systems to ensure blood product and in vitro diagnostic device quality and safety. WHO’s International Clinical Trials Registry Platform (ICTRP) compiles registered clinical trial information into a single, global search portal. Trials must register and be issued a primary identifier by one of WHO’s primary registries or its data set. Upon request, WHO issues a secondary identifier, a Universal Trial Number (UTN), to registered clinical trials.27Table 41-1lists websites for these respective guideline repositories.

Book Publishers

Several companies specialize in print and electronic publications focused on healthcare regulatory topics. This section reviews industry, government, association and standards publishers targeting the healthcare regulatory profession and explains how to retrieve the most relevant resources using online catalogs. Because regulatory is an interdisciplinary profession, publishers primarily concentrating on scientific research and development (R&D), law, medicine, business or government, or possibly all of the above, also may produce publications with a regulatory focus.

CRC Online Press, John Wiley & Sons, Lippincott Williams & Wilkins/Wolters Kluwer Health, Majors.com and Springer are major publishing firms providing broad subject coverage and featuring a numerous publications directed at the regulatory profession. The CRC Online Press website contains regulatory publications under the general category of pharmaceutical science, which can be located in the subcategories: biotechnology/biopharmaceutical; cleaning and sterilization; clinical trials; computer software; drug delivery and development; drug discovery; laboratory; manufacturing and engineering; medical devices; quality assurance; regulations and standards; and training and validation. Similarly, John Wiley & Sons produces regulatory publications on drug submissions, clinical trials, drug safety evaluation, pharmaceutical manufacturing regulations, quality and preclinical development. Lippincott Williams & Wilkins, a division of Wolters Kluwer Health, also has publications on drug development, clinical trials and pharmaceuticals. Majors.com’s publications focus on regulatory compliance; quality assurance; risk management; the Health Insurance Portability and Accountability Act (HIPAA); coding and reimbursement; administrative law and regulatory practice; pharmaceutical research; medical devices; biotechnology; chemistry, manufacturing and controls compliance; laboratory auditing; validation; and clinical research. Springer, by comparison, covers regulatory and toxicology issues such as pharmaceutical safety evaluation in its pharmaceutical science area. The following keywords are effective for searching these online catalogs:

  • regulatory
  • regulatory affairs
  • regulatory healthcare
  • pharmaceutical
  • biotechnology
  • medical device
  • pharmacology

Other industry publishers focus on such specific areas as quality assurance and standards. For example, the American Society for Quality’s (ASQ) Quality Press publishes books, standards and training materials relating to quality issues, and the Bureau of National Affairs (BNA) concentrates on legal aspects of regulatory affairs. Selected topics covered by BNA publications include pharmaceutical, biotechnology and health law, intellectual property and patent law.

Several industry publishers specialize in publications that focus entirely or largely on regulatory and compliance issues. Barnett International is one such company, publishing regularly updated reference manuals industry compendia to assist in complying with federal regulations. It also publishes regulatory industry executive analyses, question and answer guides on regulatory topics and a training series for regulatory professionals. FDAnews also prepares reference tools specifically aimed at pharmaceutical, biologics and medical device regulatory professionals. Its products include Code of Federal Regulations (CFR) compilations, an adverse event compliance series and publications on biologics, biosimilars and combination drug products. GMP Publications also targets the regulatory industry through its CFR pocket guides and Good Clinical Practice and Good Manufacturing Practice handbooks.

Thompson Publishing Group dedicates an entire product line to food and drug regulatory materials. These products generally consist of two-volume manuals containing regularly updated newsletters, an archive and special reports, in addition to access to other online resources. Topics include Good Clinical Practice, FDA advertising and promotion, FDA enforcement and medical device regulation.

Many associations, such as the Regulatory Affairs Professionals Society (RAPS) and the Food and Drug Law Institute (FDLI), publish materials intended for regulatory professionals available in their online bookstores. This book is a key example of one such RAPS’ product. In addition, RAPS publishes regulatory affairs certification (RAC) preparatory materials for the US, Canadian, EU and Global exams; self-assessment exams for each certification; and books on topics key to the development of regulatory professionals. Also included in RAPS’ bookstore are third-party publications of interest to regulatory professionals. FDLI, similarly, markets its own publications as well as third-party products addressing regulatory and legal topics. Table 41-2 provides information on several additional book publishers.

Electronic Newsletters, Magazines and Journals

Industry Resources

In addition to books, reports and standards, a number of industry resources available to regulatory professionals monitor current events and advance their knowledge of healthcare product regulation. Regulatory professionals can stay informed and save time by reviewing these industry-specific publications, as the sources reviewed in this section cover a range of drug, device and biologic regulatory publications.

Many publishers produce multiple newsletters directed at different healthcare product sectors. For example, FDAnews publishes three free e-newsletters: FDAnews Device Daily Bulletin, FDAnews Drug Daily Bulletin and The QMN Weekly Bulletin. FDAnews Device Daily Bulletin monitors FDA regulatory, legislative and business news developments and selected international news affecting the medical device industry. FDAnews Drug Daily Bulletin provides parallel coverage for the pharmaceutical industry. The QMN Weekly Bulletin covers current quality management news, regulatory developments and inspection trends. Summaries in these publications offer brief but valuable perspectives on current regulatory management issues for drugs, devices and quality. Links to the full-text articles are listed below each summary. These links afford regulatory professionals an opportunity to obtain further information on a particular subject and learn about new resources. However, many of these publications require subscriptions. In addition to FDAnews’ free e-newsletters, the company distributes 10 fee-based subscription newsletters. These include: Clinical Trials Advisor, Drug GMP Report, Drug Industry Daily, Generic Line, International Medical Device Regulatory Monitor, International Pharmaceutical Regulatory Monitor and The GMP Letter.

SmartBrief, an independent e-newsletter publisher, produces 25 industry-specific daily newsletters available free of charge with subscription. The company partners with trade associations and professional societies and publishes their newsletters. FDLI SmartBrief works with FDLI to reach food and drug industry professionals. Similarly, AdvaMed SmartBrief is issued in conjunction with the Advanced Medical Technology Association (AdvaMed) and targets medical device, diagnostic product and health information system professionals. AdvaMed is a lobbying/advocacy organization for the medical device and technology industry advancing global healthcare and increasing patient access to medical technology. AdvaMed also promotes policies encouraging high ethical standards, rapid product approvals, appropriate reimbursement and international market access. SmartBrief publication summaries are based on original information from news organizations and repackaged by the firm’s editorial staff. Each newsletter typically covers top stories: healthcare in transition, hot topics, business and market trends, science and health policy, emerging technologies and product-specific and association-specific news. Regulatory professionals can use these publications to track current regulatory developments in time-saving compilations and obtain valuable competitive intelligence.

VertMarkets has established online community marketplaces for eight industry groups to connect buyers and suppliers. For each of its online industry communities, VertMarkets produces free bi-weekly email newsletters providing not only product offerings but also industry updates and the latest news to its members. The newsletters directed to regulatory professionals fall into the life sciences category and include the BioProcess Online Newsletter, Drug Discovery Leader Online Newsletter, Life Sciences Leader Online Newsletter, Clinical Leader Online Newsletter, Laboratory Network Community Newsletter, Medical Device Online Community Newsletter and Pharmaceutical Online Newsletter. Typical content includes top news stories, featured articles, featured downloads and product showcases.

FierceMarkets is another digital media company specializing in supporting business-to-business marketing in the life sciences, healthcare, IT, telecom and finance industries through its e-newsletters, websites, webinars and live events. FiercePharma is a daily e-newsletter focusedonpharmaceutical company news and market development of FDA-approved products. In addition, the publication features FDA rulings, regulations, recalls, warnings, drug launches, drug safety information, pharmaceutical sales information and marketing news and activities of key industry professionals. FierceBiotech is another daily e-newsletter in the FierceMarkets’ digital product family. It concentrates on drug discovery and clinical trials news as well as the latest biotechnology trends, breakthroughs and FDA approval updates. FierceBiotechResearcher reports on biotechnology research news, information and tools, with a special focus on the science of drug discovery. FierceVaccines, FierceDrugDelivery, FierceDiagnostics, FierceCRO, FiercePharma Manufacturing FierceBiotechIT and FierceHealthcare are the company’s other seven e-newsletters within the healthcare division.

Another well-recognized, fee-based publisher is Informa, one of the largest publishers of business information for the pharmaceutical, biotechnology, medical devices and diagnostics industries. Its subsidiary, Informa Business Intelligence, distributes several e-newsletters monitoring business information and intelligence trends, technologies and companies in the medical device, diagnostics and biotech industry. The company’s fee-based newsletters include Medtech Insight, IN VIVO, Start-Up and The RPM Report. Medtech Insight is particularly useful to regulatory professionals for its clinical and industry perspectives on products, procedures and technologies shaping the global medical technology market. IN VIVO provides in-depth analyses of marketing, R&D and regulatory and finance strategies in the biopharmaceutical, medical technology and diagnostics industries. Start-Up examines new product and leading-edge company and investment trends in the pharmaceutical, biotechnology, medical device and in vitro diagnostics industries. The RPM Report is a useful business resource for the biopharmaceutical regulatory professional. Its focuses primarily on FDA, the Centers for Medicare and Medicaid Services (CMS) and public sector issues.

F-D-C Reports Inc., a subsidiary of the Informa Business Intelligence Unit (formerly Elsevier Business Intelligence), is another newsletter publisher serving the healthcare product industry. F-D-C Reports publishes fee-based newsletters designed to clarify developments affecting US healthcare product and services marketing and regulation for industry executives, policymakers and analysts. Newsletters published by F-D-C Reports include: The Pink Sheet/The Pink Sheet DAILY, Pharmaceutical Approvals Monthly, The Gold Sheet and PharmAsia News in the pharmaceuticals and biotechnology category; The Silver Sheet and The Gray Sheet in the medical devices and diagnostics category; The Tan Sheet and The Rose Sheet in the consumer products category; and Health News Daily in the health policy and biomedical research category. Although the majority of its publications are fee-based, it does offer a complimentary subscription to a few of its weekly e-newsletters. One of these publications, Medical Devices Today, provides strategy, regulation, innovation and investment coverage from The Gray Sheet, Medtech Insight, IN VIVO, Start-Up, The Silver Sheet, The Pink Sheet and Strategic Transactions. The articles cover drug and business development, finance, strategy, regulation and reimbursement.

Another key regulatory publication by Informa is SCRIP Regulatory Affairs (SRA, formerly Regulatory Affairs Journal Pharma/Devices).SRA serves as a source of global news, commentaries and analyses of regulation in the pharmaceutical and biotechnology industries. The publication provides pharmaceutical regulatory intelligence on global regulations governing the development, launch and postmarket surveillance of medicines and combination products. Areas of coverage include: regulatory agencies and legislation, application requirements and guidelines, R&D, patents and intellectual property, international harmonization, pediatric legislation, pharmacovigilance, pharmacoeconomics and drug safety. Informa Healthcare also produces a broad range of fee-based industry news sources (e.g., Scrip World Pharmaceutical News), business and market research reports, R&D analytical tools and databases (e.g., Pharmaprojects and TrialTrove) and research journals (e.g., Clinical Research & Regulatory Affairs, Drug Development and Industrial Pharmacy).

The medical device industry also receives excellent web coverage through a number of free publications. Medical Device & Diagnostic Industry (MD&DI) is one of 13 magazines published by UBM Canon (formerly Canon Communications) focusing on the medical technology industry. MD&DI is a monthly magazine written exclusively for original equipment manufacturers of medical devices and in vitro diagnostic products. The publication supports industry efforts to comply with regulations, keep up-to-date on current events, improve manufacturing and design processes and understand market demand. QMed Daily is another UBM Canon publication available free of charge with membership to QMed, formerly Medical Device Link. QMed Daily is a daily e-newsletter reporting on top industry headlines and important FDA announcements and features articles on technology breakthroughs in the medical device industry worldwide. QMed also offers subscriptions to the Consultants Corner newsletter, which focuses on the development and commercialization of medical products, and the MPMN Medtech Pulse newsletter, which provides news on emerging medical technologies.

In addition, Dickinson’s FDAReview is a monthly newsletter published by Ferdic Inc. providing in-depth analyses of the medical device and drug industries as well as FDA inspection and enforcement activities, including Freedom of Information Act (FOIA) daily logs and Warning Letter summaries. FDAUpdate is a weekly fax document containing FR updates pertaining to FDA rules and regulations; newly released Warning Letters; weekly filed Citizen Petitions; Advisory Committee proceedings and calendars; and late-breaking FDA and pharmaceutical product news. Free items also available on Dickinson’s interactive website, FDAWebview, include FDA Warning Letters, FR notices and an FDA calendar.

A few other free electronic industry-specific resources worth mentioning briefly are MedicalDeviceSummit, Today’s Medical Developments Magazine, Marketing News, in-PharmaTechnologist.com, Pharmaceutical Technology Magazine, PharmTech.com and Pharmafile.com. Clinical monitoring news is addressed in a free weekly e-newsletter entitled, BioPharm Insight and BioPharm Clinical, published byInfinata. The newsletter covers the latest information on clinical enrollments, clinical results, drug approvals, drug licensing and medical devices.

VirSci Corporation’s Pharma Marketing News is a monthly newsletter for pharmaceutical and marketing professionals designed to keep subscribers informed about industry trends and innovations. It also offers a professional network for career advancement. Frequently covered topics include: physician marketing, sales and education, regulatory compliance, patient education and direct-to-consumer advertising and marketing. Outcomes LLC (formerly UBM Canon and Canon Communication) is another publisher offering a free monthly magazine, Med Ad News,andthe site, PharmaLive.com, which provides news updates for the pharmaceutical industry. The magazineis an established resource for competitive business intelligence and marketing strategy information. Last, TradePub.com is excellent source for free healthcare and medical magazines, publications and newsletters covering the pharmaceutical and medical device industries and more.

Global Regulatory Press’ Journal of Medical Device Regulation is yet another important resource for medical device regulatory professionals. This is a quarterly publication currently available only in electronic format. Regulatory professionals can monitor global regulatory developments through legislative changes summarized in each issue and obtain guidance from review articles analyzing current medical device regulatory and compliance issues.

The list of free and fee-based regulatory publications is long and varied, ranging from industry newsletters and peer-reviewed journals to association magazines. This section provides a snapshot of some of these resources. These publications, although not exhaustive of all available resources, provide regulatory professionals a solid basis for further independent research.

Association Resources

The majority of association publications are free with membership but require nonmembers to pay an annual membership fee. RAPS is one such association, publishing a monthly electronic magazine, Regulatory Focus, which is available to its members, with limited online guest access to selected articles. The magazine focuses on current regulatory issues affecting the drug, medical device and biological healthcare product sectors. As an offshoot from the magazine, RAPS provides daily (weekdays only) news briefings via RF Today, featuring summaries of the top regulatory news stories from around the world relating to pharmaceuticals, medical devices, biotechnology and the agencies that regulate them. Another RAPS member-based resource is a weekly e-newsletter, RAPS Weekly Update. Similarly, The Organisation for Professionals in Regulatory Affairs (TOPRA) publishes a members-only international journal, Regulatory Rapporteur, which provides current news and analyses on regulatory and legislative topics. TOPRA also issues a quarterly member newsletter, In Touch, which serves as an association news digest covering member and organizational activities.

In addition, FDLI publishes a quarterly magazine, the Food and Drug Law Journal, which is available free to members and by subscription to the public. The journal features articles on food, drug, cosmetic, medical device and healthcare technology industry regulation and legislation, implications of proposed regulations, policy trends and analyses of judicial decisions in food and drug law. Its members-only resource,Update, is issued bimonthly and contains the latest association and industry news, viewpoints on industry-specific trends, FDA agency developments and articles on various regulatory topics. In addition, FDLI publishes Food and Drug Policy Forum to discuss policy, and Primers to provide guidance on trending topics in food and law.

The Medical Device Manufacturers Association (MDMA) represents the interests of smaller, entrepreneurial medical technology companies through its advocacy and educational services. Its members-only publications include the Weekly MDMA Update and the Monthly Member Services Newsletter.

The Drug Information Association (DIA) publishes its official bimonthly journal, Therapeutic Innovation & Regulatory Science (formerly the Drug Information Journal).This newly launched journal encompasses drug, device and diagnostic innovations, global regulatory topics as well as pharmaceutical research and development issues. DIA produces Global Forum, a bimonthly magazine dedicated to global coverage of pharmaceutical and medical products from discovery and development to regulation, marketing and surveillance. Global Forum also delivers up-to-date association and member news. In addition, DIA’S e-newsletter, DIA Daily, provides news highlights and information about the pharmaceutical, biotechnology and medical device fields from thousands of global news sources.

The Parenteral Drug Association’s (PDA) membership publication, PDA Letter,reports on science, technology, quality, regulatory affairs, association news and updates relevant to the PDA community. The PDA Journal of Pharmaceutical Science and Technology is a bimonthly publication containing peer-reviewed scientific and technical papers covering the pharmaceutical and biotech industries. The journal is distributed as a member benefit and also is available by subscription. PDA Technical Reports are global consensus documents addressing a range of topics relating to pharmaceutical production, validation and quality assurance. Expert task forces prepare the reports, which then are reviewed by technical forums and ultimately evaluated and approved by an advisory board and the PDA board of directors.

Within the biologics/biotechnology sphere, the Biotechnology Industry Organization (BIO) supports professionals engaged in the research and development (R&D) of new healthcare technology, biotechnology and related fields through its advocacy, business development and communications services. Its members-only publication, BIO Newsletter is published weekly and disseminated via email. The newsletter reports on organizational activities, professional perspectives on industry issues and member activities.In cooperation with the SmartBrief publisher,BIOalsoproduces BIO SmartBrief, which focuses on news updates within the biotechnology industry.

The Society of Biomaterials is one of many professional scientific organizations in which regulatory professionals can participate to keep abreast of the latest innovations and technology relevant to their products. The society promotes progress in biomedical materials research and development. Members are afforded free access to its news magazine, Biomaterials Forum, which is available by subscription to nonmembers. The forum reports on current biomaterials community activities and includes book reviews, technical briefs and professional services information. The Journal for Biomedical Materials Research is the society’s official journal and is a peer-reviewed publication provided free to members. It features clinical studies and research reports on a range of topics, including the preparation, performance and development of new biomaterials. Applied Materials is published as Part B of the journal. It contains peer-reviewed articles on device development, implant retrieval and analysis, manufacturing, regulation of devices, liability and legal issue, standards, reviews of device and clinical applications.

Two key associations in the clinical research area are the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA). In addition to its free biweekly email newsletter, ACRP Wire, ACRP also publishes a bimonthly journal, the Clinical Researcher (formerly The Monitor),featuring peer-reviewed articles, association news and a guide to certification preparation courses and exams available only to members. SoCRA, like ACRP, is dedicated to the continuing education and development of its members and publishes the SoCRA Source Journal, a members-only quarterly publication containing scientific and professional articles; society news and events; and professional opportunities and services. Selected articles from past issues of the journal are available to the public on SoCRA’s website. A comprehensive list of all the fee-based and free publisher resources reviewed and their corresponding website addresses is provided in Table 41-2.

Regulatory Collaboration: Meetings & Education

The delivery of safe, effective and high-quality healthcare products to the general public is the primary goal of any regulatory professional. With the increase in electronic submissions and online repositories, and the departmentalization of many healthcare businesses, a regulatory professional runs the risks of working in a silo. Thus, it is vital for regulatory professionals to seek opportunities for internal organizational collaboration, as well as externally across businesses, functional areas, product lines, customer-base and/or geography. Meetings and additional resources offered by industry, associations and FDA provide an opportunity for collaboration and innovation related to common challenges across businesses. Similarly, new or proven solutions to regulatory challenges can be provided by a consulting firm. This section discusses the benefits and role of associations, FDA public meetings and consulting firms to the regulatory professional.

Associations and Continued Learning

The knowledge garnered from publications, government databases and other agency resources unquestionably has an integral place in a regulatory professional’s career development. These resources enable the regulatory professional to monitor the latest news, track the status and development of laws, regulations and guidelines and engage in effective strategic product development.

In addition, associations are indispensable educational resources for regulatory professionals. Through the active participation of their members, these associations embody the immediate focus and future direction of the specific interest areas they serve. The organizations mentioned earlier in the chapter, including RAPS, DIA, TOPRA, BIO, AdvaMed, FDLI and ACRP, offer a broad variety of learning opportunities to their members. Table 41-4 provides a comprehensive but not exhaustive list of associations providing learning resources for their members and/or non-members.

Table 41-4. Societies, Trade Associations, Advocacy Groups and Associations Providing Learning Resources

Organization

Website

Learning Resources

American Association of Blood Banks (AABB)

www.aabb.org

e-Learning, Meetings, Webinars

American Association of Homeopathic Pharmacists (AAHP)

www.aahp.info

Webinars

American Association of Pharmaceutical Studies (AAPS)

www.aaps.org

e-Learning, Meetings, Webinars*

American Association of Tissue Banks (AATB)

www.aatb.org

Meetings, Webinars, Training, Certification

Association for the Advancement of Medical Instrumentation (AAMI)

www.aami.org

e-Learning, Meetings, Webinars Certifications*

Association of Clinical Research Professionals (ACRP)

www.acrpnet.org

e-Learning, Meetings, Webinars, Training, Certifications*

Advanced Medical Technology Association (AdvaMed)

www.advamed.org

e-Learning, Meetings, Webinars*

American Herbal Products Association (AHPA)

www.ahpa.org

e-Learning

Association of Medical Diagnostics Manufacturers (AMDM)

www.amdm.org

Meetings

American Society for Quality (ASQ)

www.asq.org

e-Learning, Meetings, Webinars, Training, Certifications*

Association of Veterinary Biologics Companies (AVBC)

www.avbc.net

Meetings

Biotechnology Industry Organization (BIO)

www.bio.org

Meetings

Consumer Healthcare Products Association (CHPA)

www.chpa.org

Meeting, Webinar, Training

Drug Information Association (DIA)

www.diahome.org

e-Learning, Meetings, Webinars, Training, Certificate Programs

Food and Drug Law Institute (FDLI)

www.fdli.org

Meetings

Generic Pharmaceutical Association (GPhA)

www.gphaonline.org

Meetings

Healthcare Distribution Management Association (HDMA)

healthcaredistribution.org

Meetings, Webinar*

Independent Cosmetic Manufacturers and Distributors (ICMAD)

www.icmad.org

Webinars*

Medical Device Manufacturers Association (MDMA)

www.medicaldevices.org

Meetings, Webinars*

Natural Products Association (NPA)

www.npainfo.org

Meetings, Webinars

Personal Care Product Council (PCPC)

personalcarecouncil.org

Meetings, Webinars

Parental Drug Association (PDA)

www.pda.org

e-Learning, Meetings, Training

Plasma Protein Therapeutics Association (PPTA)

www.pptaglobal.org

Meetings

Regulatory Affairs Professionals Society (RAPS)

www.raps.org

e-Learning, Meetings, Webinars, Training, Certification*

Society of Clinical Trials (SCT)

www.sctweb.org

Meetings, Webinars*

Society of Clinical Research Associates (SoCRA)

www.socra.org

e-Learning, Meetings, Training, Certifications

The Organisation for Professionals in Regulatory Affairs (TOPRA)

www.topra.org

e-Learning, Meetings, Degree Programs

World Medical Device Organization (WMDO)

www.wmdo.org

e-Learning, Certifications, Certificate Programs

*Resource may be fee-based or free.
The absence of an asterisk indicates that the resource is fee-based. However, costs for members may differ.
Note: Website URLs are current at time of publication.

Most associations require a nominal membership fee, which grants individuals (or in some cases designated company representatives) access to member-only resources. These resources may include:

  • discounts to the organization’s resources, i.e., webinars and publications
  • access to knowledge databases, reports, directories
  • access to the latest news specific to the organization’s focus via periodic newsletters, email updates and/or social media outlets
  • access to education tools, i.e., e-learning and seminars
  • access and/or discounts to the resources of partner associations
  • access to member directories and online forums
  • participation in meetings, trade shows and/or conferences
  • involvement in special partnerships and/or meetings with direct interaction with compliance bodies and regulatory agencies
  • networking with other professionals with similar expertise or regulatory interests
  • assistance with business and/or regulatory activities
  • advocacy for the professional and/or an organization’s professional interests
  • participation on committees influencing the organization’s vision and direction

Participation in these associations grants access and opportunities for learning through professional networking, committee involvement and educational tools. Regulatory professionals can maintain their knowledge of the regulatory healthcare industry and/or fulfill core competency requirements by participating in e-learning courses, web-based training, interactive web-based webinars and/or online certificate programs.

Webinars may be open to members and nonmembers depending on the organization. These webinars offer live, virtual group learning sessions, in which the presenter(s), a subject matter expert, focuses on a specific topic and opens the floor to attendees for discussion and questions. Typically, the presentation is in Microsoft PowerPoint format, but also may reference a regulatory document, database or any other pertinent resource.

Alternatively, e-learning resources provide archived learning sessions accessible at the regulatory professional’s convenience, where the learner sets the pace of the online coursework. RAPS, DIA and the World Medical Device Organization (WMDO) provide e-learning curricula culminating in a certificate. DIA offers certificates in clinical research, regulatory affairs, clinical safety and pharmacovigilance, project management and medical communications. WMDO provides educational opportunities to regulatory professionals in the medical device arena, with certificates in clinical evaluation, Asia-Pacific and EU medical device regulatory affairs and medical device monitoring. A combined medical device and pharmaceutical regulatory affairs certificate is offered by RAPS, as well as individual certificates within each topic. Formal postgraduate degree programs (online and classroom settings) are offered by several universities. Uniquely, TOPRA offers a Masters of Science in Regulatory Affairs, which is formally validated by the University of Hertfordshire. The program requires the completion of e-Learning modules on regulations, regulatory strategy, clinical operations, regulatory submissions and product development. It also requires the submission of a research-based dissertation.

Organizations such as the American Association of Tissue Banks (AATB), ACRP, ASQ, RAPS and SoCRA provide industry-recognized certifications specific to their respective specialties: tissue banking, clinical research, quality (i.e., auditing, engineering or improvement), regulatory affairs and clinical investigations, respectively. Certification typically requires achieving a passing score on an association-administered standardized exam offered several times throughout the year.

AATB, ACRP, ASQ, the Consumer Healthcare Products Association (CHPA), PDA and SoCRA provide face-to-face and/or virtual training sessions. CHPA serves as a trade association for manufacturers and distributors of OTC medicines and dietary supplements. They offer periodic face-to-face training sessions on compliance with current Good Manufacturing Practice (CGMP). PDA seeks to connect people, science and regulation through the development and coordination of scientific, technical and regulatory information germane to the pharmaceutical and biopharmaceutical communities. In support of its mission, PDA offers several courses in such areas as aseptic processing, filtration, environmental monitoring, biotechnology, microbiology, process validation and quality/regulatory affairs, among other topics.

Typically, association members have access to periodic association meetings and conferences where in-person classroom workshops and training sessions may be offered to registrants. Less didactic learning occurs at annual meetings, conferences or seminars held or co-sponsored by the associations listed in Table 41-4. These meetings allow regulatory professionals and other industry-related professionals to become acquainted, learn about key topics and engage in discussions related to changes in the regulatory healthcare industry over the course of one to seven days, depending on the meeting topics and organization’s size. Note the American Herbal Products Association (AHPA), a scientific and regulatory advocate organization for herbs, botanicals and herbal products, and the Independent Cosmetic Manufacturers and Distributors (ICMAD) association, do not host meetings but participate in industry exhibits, trade shows and expos. WMDO also does not host or participate in meetings, as it focuses on distance, online learning.

In addition to offering formal learning options, associations enable professionals to engage in networking and information exchange with their colleagues through forums and online communities. Along with their periodic national meetings, numerous associations implement monthly or quarterly programming at the local, chapter level across the US to support ongoing networking and professional development activities. In concert, these association tools support the continued learning of the regulatory professional.

FDA Meetings

FDA accepts requests for formal meetings to discuss product development and regulatory submissions, and also sponsors and co-sponsors meetings, workshops and other events open to the general public. (Chapters 4 and 5 provide detailed discussions of FDA formal meetings and Advisory Committee Meetings, respectively.) FDA announces upcoming, scheduled sponsored and co-sponsored events, along with presentations by FDA representatives on its website. The website organizes the meeting announcements by topic (Advisory Committee calendar, animal and veterinary, biologics, combination products, cosmetics, drugs, food, medical countermeasures, medical devices, science and research and tobacco products), typically a month or more in advance. Attendance at FDA-sponsored events, whether in-person or via webcast (Adobe Connect, web conference software) requires registration, which is accepted on a first-come, first-serve basis due to limited seating. Registration is free. However, for co-sponsored events, registration and related fees may apply. FDA posts Advisory Committee Meeting announcements at least 15 calendar days before a meeting date in accordance with 41 CFR Section 102-3.150. In addition, FDA announces sponsored stakeholder meetings on its website a few days before the teleconference.28

Through these periodic stakeholder meetings, FDA aims to gain input from the general public, particularly consumer organizations, researchers, scientists and industry representatives, on public health actions and initiatives. Subsequent to meetings and workshops, FDA posts a text or PowerPoint version of presentations, meeting materials (FR notice, agenda and panelists) and/or webcasts on its website.

Consulting Firms

Regardless of a healthcare company’s size, knowledge gaps arise within a regulatory team, warranting the need for an external consultant’s expertise. These consultants execute a myriad of functions and offer knowledge in areas including, but not limited to product regulations, trade compliance, customs regulation, clinical research/trials, testing (laboratory or animal), data management, quality management, auditing, reimbursement, medical writing and due diligence. Hundreds of consulting companies exist to support industry needs during all product lifecycle phases. Numerous associations and media portals offer listings and rankings of consulting services. For example, QMED offers a directory of vetted consultants, organized by service for the medical device and in vitro diagnostics industry.29 These directories serve as a starting point for identifying a consulting firm. In some cases, the consulting firm’s website may serve as an online knowledge tool, e.g., the medical device consulting firm, Emergo Group Inc. offers an open-access digital library of articles, charts, reports, regulations and archived webinars.30 In addition, Centerwatch, a service provider of clinical trials information, offers access to white papers, clinical trial databases and a directory of consulting firms/services.31 Given the complexity and dynamism of the healthcare field, consultants’ extensive knowledge can be a useful asset for a regulatory team.

Social Networking and Mobile Apps

The second generation of Internet-based services goes beyond static web content and commonly is referred to as Web 2.0. It encompasses social networking and other forms of dynamic and interactive information sharing by users. Given the pervasiveness of smart phones, tablets and other innovations in web and mobile technology, consumption of real-time, up-to-date information by end users of these devices goes beyond entertainment, and has important application for news and information retrieval. Users expect opportunities for community-based input and daily or minute-to-minute content-sharing in their respective professional fields. To complement the networking benefits of industry association memberships, regulatory professionals now can connect with colleagues through blogs and social networking websites. The regulatory professional has several options through which to receive information:

  • Tumblr/Blogs/Microblogs—regularly updated journal entries designed to be read by a professional audience and representing the unique personality of the author or website; multimedia postings with commenting features (more information provided below)
  • LinkedIn—microblogging/networking tool for professionals, organizations and businesses (more information provided below)
  • RSS feeds—automated tracking of updates to favorite websites (more information provided below)
  • Twitter—microblogging of videos, photos and status/activity updates, with commenting features
    Example: FDA Recalls and FDA MedWatch provide safety and recall updates32
  • YouTube—public video sharing with captioning and commenting features
    Example: USPTO video series on applications33
  • Facebook—microblogging/networking tool for sharing videos, photos and status/activity updates with commenting features
    Example: NIH Research Matters provides a weekly review of NIH-funded research34
  • Google Plus+—microblogging/networking tool for sharing videos, photos and status/activity updates with commenting features
    Example: RAPS.org provides daily RAPS-specific and general regulatory news35

Government agencies and other industry associates already have adopted numerous Web 2.0 information tools, particularly social media outlets and information feeds, as a pathway to engage consumers, healthcare professionals and regulatory professionals. With the exception of the Plasma Protein Therapeutics Association (PPTA) and the Academy of Veterinary Behavior Technicians (AVBT), all other trade associations, advocacy groups and associations listed on Table 41-4, and all of the US agencies, organizations, institutes, centers and offices listed in Table 41-1 utilize Web 2.0 tools (specifically social media). FDA provides web content devoted to staying informed via subscriptions,36 RSS feeds and interactive media.37

RSS (Rich Site Summary, Really Simple Syndication) news feeds automatically track website content updates (news, blogs, audio, video and images), sending content to subscribers automatically. RSS allows users to collect and organize information from websites, commonly referred to as feeds. The RSS feed can be synched to Microsoft Outlook to receive scheduled email updates. RSS feed aggregators (also referred to as readers) are available for download, both commercially and open access. The RSS feed tool along with direct email subscriptions to government websites, organizations/societies and blogs offer the regulatory professional convenient periodic updates.

Some of the more popular blogs within the regulatory healthcare sector include: FDA Voice (official FDA blog); FDA Law Blog (Hyman, Phelps & McNamara PC); Biotech Blog (managed by Yali Friedman, PhD); Eye on FDA (RX for Pharma Industry Communications and Planning); and Medical Device and Diagnostic Industry (MDDI) blogs, including Device Talk. This list does not begin to scratch the surface of the widely available regulatory information; however, it is a good starting point.

In addition, regulatory professionals can participate in sites such as LinkedIn to establish public professional profiles, search for jobs, interact with colleagues, search for other regulatory professionals and join online regulatory groups. LinkedIn operates the world’s largest professional network on the Internet, with more than 300 million members in over 200 countries and territories.38 Joining the network is free and simply requires the user to create a profile summarizing his or her professional experience and accomplishments. The information a user chooses to make available publicly can be searched by other professionals within the LinkedIn network and used for the purpose of meeting and collaborating with other members.

LinkedIn hosts a multitude of regulatory groups supporting regulatory professionals’ interaction. The Quality and Safety Regulatory Network on LinkedIn supports professionals working in quality assurance, regulatory and compliance in highly regulated industries. This group allows professionals to share experiences and expand their networks of people and ideas in quality, regulatory, safety, health, sustainability, risk and compliance for continuous improvement across multiple industries.39 Similarly, the reg-info.com group on LinkedIn allows pharmaceutical professionals to share ideas and participate in a forum for issues related to regulatory intelligence and information gathering. This community also assists pharmaceutical professionals in finding regulatory intelligence information through links to key regulatory and related information sources.40

Other social networking sites, such as Pinterest, Instagram, Flickr and Foursquare, are not covered in this discussion, as they have not yet been adopted widely as useful platforms for regulatory intelligence and/or information sharing. Notably, mobile application technology has emerged within the last decade as a tool for quick, user-friendly information retrieval on smartphones. However, the adoption of downloadable mobile applications (“apps”) for regulatory content still is in its nascent stage. In March 2015, FDA released the agency’s first free, mobile app focused on relaying updates and the status of FDA drug shortages. In addition, the Emergo Group Inc. offers a free, mobile app providing access to regulatory intelligence, including the full text of the FDA QSR (21 CFR Part 820). Ultimately, the continued use of Web 2.0 technology and growing adoption of mobile apps will support increased interactions and collaboration across the regulatory field.

Summary

Regulatory professionals have improved their productivity, effectiveness and expertise significantly through ever-increasing access to an array of Internet-based regulatory resources. The ease with which regulatory information can be acquired is profound, compared to less than a decade ago when the only way to acquire similar information was through mail, fax and/or telephone. This chapter reviews a wide range of information resources and social networking tools available to regulatory professionals. The number of publications and databases, and government, association and industry web-based tools, as well as social networking opportunities developed in just the past few decades is staggering. The new challenge for regulatory professionals is to distill the essential knowledge they require from the vast storehouse of information available to perform their jobs as effectively as possible. This will require carefully managing subscriptions, becoming skilled in using relevant government and industry databases, making use of associations’ educational resources to advance professional knowledge, leveraging the expertise of consulting firms as needed and using social networking tools with discipline and discernment. In this way, regulatory professionals will be certain to reap the greatest benefit from the abundant resources available, and thereby ensure the public receives safe, effective and quality healthcare products.

References

  1. About GPO. GPO website. www.gpo.gov/about/. Accessed 21 January 2015.
  2. Federal Register E-Mail Updates. National Archives website. http://www.archives.gov/federal-register/the-federal-register/email-signup.html. Accessed 21 January 2015.
  3. GPO homepage. http://www.gpo.gov. Accessed 21 January 2015.
  4. Regulatory Information. FDA website. http://www.fda.gov/RegulatoryInformation . Accessed 21 January 2015.
  5. Regulations.gov home page. http://www.regulations.gov. Accessed 21 January 2015.
  6. Congress.gov home page. http://thomas.loc.gov/ . Accessed 23 January 2015.
  7. Intellectual Property Rights Search. Customs and Border Protection website. http://iprs.cbp.gov . Accessed 23 January 2015.
  8. Customs Rulings Online Search System (CROSS) Data.gov website. https://catalog.data.gov/dataset/cbp-customs-rulings-online-search-system-cross . Accessed 23 January 2015.
  9. Letter to Industry about Import Entry Review Process (September 6, 2011). FDA website. http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm271180.htm. Accessed 3 February 2015.
  10. https://www.bis.doc.gov/index.php/enforcement/oac. Accessed 21 January 2015.
  11. Training and Continuing Education. www.fda.gov/Training. Accessed 30 June 2015.
  12. Ask Us: FDA Basics Webinar Series. www.fda.gov/AboutFDA/Transparency/Basics/ucm197102.htm. Accessed 30 June 2015.
  13. About Us and Dun & Bradstreet - FDA DUNS Request. www.dnb.com/government/duns-request.html. Accessed 30 June 2015.
  14. D&B D-U-N-S® Number Lookup. www.dandb.com/dunsnumberlookup. Accessed 30 June 2015.
  15. PharmaPendium Interoperability. www.elsevier.com/solutions/pharmapendium/interoperability. Accessed June 30, 2015.
  16. About ClinRegs. clinregs.niaid.nih.gov/about.php. Accessed 12 February 2015.
  17. Tarius Solutions. www.tarius.com. Accessed 2 July 2015.
  18. Cortellis Regulatory Intelligence Overview. thomsonreuters.com/en/products-services/pharma-life-sciences/regulatory-affairs/product-overview.htm. Accessed 30 June 2015.
  19. Health home page. http://www.wolterskluwerlb.com/health Accessed 30 June 2015.
  20. Trialtrove home page. citeline.com/products/trialtrove. Accessed 30 June 2015
  21. Pharmaprojects home page. citeline.com/products/pharmaprojects. Accessed 30 June 2015
  22. International Standard for Organization home page. iso.org. Accessed 21 January 2015.
  23. About USP—An Overview. US Pharmacopeia website. www.usp.org/about-usp. Accessed 21 January 2015.
  24. About ICH. www.ich.org. International Conference on Harmonisation website. Accessed 4 January 2015.
  25. About PhRMA. http://www.phrma.org/about. Pharmaceutical Research and Manufacturers of America. Accessed 11 February 2015.
  26. International Medical Device Regulators Forum home page. www.imdrf.org. Accessed 4 January 2015.
  27. International Clinical Trials Registry Platform (ICTRP) home page. http://www.who.int/ictrp/en/. World Health Organization website. Accessed 11 February 2015
  28. FDA Stakeholders Events home page. http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/StakeholderMeetings/default.htm. FDA website. Accessed 11 February 2015.
  29. Qualified Supplier Directory. www.qmed.com/supplier-categories/consultants. Accessed 2 July 2015
  30. Resource Library for Medical Device Professionals. http://www.emergogroup.com/resources. Accessed 2 July 2015
  31. Centerwatch News Resources. www.centerwatch.com/news-resources. Accessed 2 July 2015
  32. FDA recalls Twitter site. FDA website. https://twitter.com/fdarecalls; FDA MedWatch twitter site. https://twitter.com/FDAMedWatch. Accessed 12 February 2015.
  33. USPTO on youtube. https://www.youtube.com/user/USPTOvideo/videos. Accessed 12 February 2015.
  34. NIH Research Matter. https://www.facebook.com/ResearchMatters. Facebook website. Accessed 12 February 2015.
  35. Regulatory Affairs Professionals Society. https://plus.google.com/106321095709510076478/posts. Accessed 12 February 2015.
  36. FDA Stay Informed. www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234630.htm. Accessed 1 July 2015.
  37. FDA Interactive Media. www.fda.gov/NewsEvents/InteractiveMedia. Accessed 1 July 2015.
  38. Linkedin home page. www.linkedin.com/about-us. Accessed 12 February 2015.
  39. Linkedin Quality & Regulatory network. https://www.linkedin.com/groups?gid=80327. Accessed 12 February 2015.
  40. reg-infor.com—Regulatory intelligence for pharma. https://www.linkedin.com/grp/home?gid=833547. Accessed 12 February 2015.

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