Featured Articles

In-depth examination and analysis of regulatory and related topics, available exclusively to RAPS members.

Bioequivalence Studies of Solid Oral Dosage Forms Overview

The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.

Categories: Generic drugs, Features, FDA, EMA, Health Canada, MHLW, PMDA, TGA, WHO Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability
Organizational Culture and Memory in Managing Risk in the Medical Device Industry

This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality."

Categories: Medical Devices, Business Skills, Features, US, FDA Tags: Risk Management, Organizational Culture
Is Increasing Antibiotic Resistance Driving Bacteriophage Therapy Closer to Being a Reality?

This article reviews the history of bacteriophage discovery, biology, and potential medical uses, and discusses therapeutic pros and cons compared to and potentially replacing antibiotics due to increasing antibiotic resistance. The article also highlights the future of phage therapy and the need for more scientific investigation and clinical trials prior to approval for human use and the possible patenting and regulatory issues impacting bacteriophage development. The US Food and Drug Administration (FDA) recently covered issues related to bacteriophage development during a workshop in July 2017.

Categories: Biologics and biotechnology, Features, FDA Tags: Bacteriophage, Phage, Antimicrobial Resistance
Resources and Training for Regulatory Professionals

This article discusses the knowledge path for regulatory professionals from a career's early stages through specialization. It recommends a variety of ways to keep current on evolving regulatory issues, including on-the-job training, self-education via the Internet, attending conferences, networking, and membership in professional organizations.

Categories: Career Development, Regulatory intelligence, Features, Business and Leadership Tags:
Pharmaceutical Cleaning Processes

This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification.

Categories: Drugs, Features, FDA, WHO Tags: Cleaning, Washing, Rinsing, Cleaning Validation
Ten Secrets to Regulatory Success

This article highlights "10 secrets to success" for regulatory professionals that may not be taught in formal regulatory affairs training programs, but practices the author learned "on the job." It includes suggestions for developing regulatory submissions and the importance of good writing, doing your "homework" and systematizing work procedures.

Categories: Career Development, Features, Communication Tags:
Regulatory Career Progression

This article discusses pathways for a career as a regulatory professional and possible career progression from junior to senior to managerial level. It summarizes the skills required for each level and what it takes to move up the corporate ladder. It also provides the responsibilities expected of a regulatory professional in a senior management position.

Categories: Career Development, Career Search, Features, Business and Leadership Tags: Career Development, Regulatory Profession
FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities

The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).

Categories: Drugs, Compliance, Manufacturing, Features, US, FDA Tags: Oral Solid Dosage, OSD, Inspections
Biological Products and Biosimilars: Global Naming Debate

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: Biologics and biotechnology, Submission and registration, News, US, Canada, Europe, Asia, Oceania, FDA, EMA, Health Canada, PMDA, TGA, WHO Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN
Medicinal Product Registration in Egypt

This article provides an overview of Egypt's New Drug Application (NDA) procedure for imported brand pharmaceutical products, including new chemical entities and biologics. It discusses the various Egyptian Drug Authority (EDA) departments and the required procedures for moving products through registration and into the market.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Submission and registration, Features Tags: EDA, Egyptian Drug Authority
Identification of Medicinal Products (IDMP) Standards Part 4: Technical Approaches to IDMP

This article discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards with regard to generating, collecting and mapping accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market.

Categories: Biologics and biotechnology, Drugs, Features, US, Europe, FDA, EMA, ISO Tags: Identification of Medicinal Products, IDMP
Regulating Pediatric Studies: An EU and US Perspective

This article presents pediatric regulatory activities conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and highlights global harmonization efforts, collaborative discussions and regulations for pediatric clinical trials.

Categories: Biologics and biotechnology, Drugs, Clinical, Features, US, Europe, FDA, EMA Tags:
Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.

Categories: Drugs, Submission and registration, Features, US, Canada, Europe, Japan, Oceania, FDA, EMA, Health Canada, PMDA, TGA Tags: Quality Certificates, eCTD, GMP
Conditional Approvals for Early Access to New Medications

This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, US, Europe, Japan, FDA, EMA, PMDA, ICH Tags: Conditional approval, Regenerative medicine
Navigating the Medical Device User Fee Act (MDUFA)

This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.

Categories: Medical Devices, Submission and registration, Features, US, CDRH Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees
ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Categories: Biologics and biotechnology, Drugs, Quality, Features, US, Europe, FDA, ICH Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD
Generic Drug User Fee Act (GDUFA): Overview and Proposed Changes for 2018

This article discusses aspects of the Generic Drug User Fee Act enacted by Congress as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), including fees, changes enabling FDA to speed up reviews, GDUFA goals and proposed changes and impacts as the first five–year phase concludes in 2017.

Categories: Generic drugs, Submission and registration, Features, US, FDA Tags: GDUFA
Regulatory Harmonization Initiatives

This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Compliance, Features, US, Canada, Europe, Asia, Latin America and Caribbean, Africa, Middle East, Oceania, ICH, IMDRF, GHTF, APEC, OECD, WHO, ISO Tags: Harmonization
FDA User Fee Programs

This article provides an overview of upcoming important changes to FDA's major user fee programs (PDUFA VI, MDUFA IV and GDUFA II) for Fiscal 2018–2022. It discusses new performance goals, additional commitments FDA has agreed upon with industry and how these changes could impact various types of industry submission strategies.

Categories: Biologics and biotechnology, Generic drugs, Medical Devices, Submission and registration, News, US, FDA Tags: User Fees, PDUFA, MDUFA, GDUFA
Thailand's Approach to Drug Quality Assurance: Creation of the Green Book

This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.

Categories: Drugs, Quality, Features, Asia Tags: Thailand, Green Book, Quality Assurance
Identification of Medicinal Products (IDMP) Standards Part 3: Steps to Prepare for IDMP Implementation

This article discusses the gap analysis and preliminary activities necessary to prepare a pharmaceutical company for the upcoming IDMP standards; it is the final article in a three part series on the standards and their respective implementation guidelines. The first two articles presented reasons for the new standard, the driving forces behind IDMP, and the concepts behind the standard as well as the current timelines for introducing IDMP in worldwide markets.

Categories: Drugs, Features, FDA, EMA, ISO Tags:
The Prescription Drug User Fee Act (PDUFA): A Primer

This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, FDA Tags: User Fees, Prescription Drug User Fee Act, PDUFA
Impact of the Revised EU Clinical Trial Regulation

Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.

Categories: Biologics and biotechnology, Drugs, Clinical, Features, Europe, EMA, EC Tags: Clinical Trial Regulation, EU No 536/2014
Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products

This article summarizes regulatory changes impacting how premarket applications for combination products will be reviewed by FDA and procedures and reporting requirements for applicants and FDA as required by the 21st Century Cures Act.

Categories: Biologics and biotechnology, Combination products, Drugs, Medical Devices, Features, US, FDA Tags: 21st Century Cures Act, Combination Products, Primary Mode of Action, PMOA
Strategies Adopted by Innovator Companies in Response to Biosimilars Competition

This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration, Features, US, Europe, FDA, EMA Tags: Biosimilars, Intellectual Property, Litigation, Patent Extension
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