Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 03 February 2014
The US Food and Drug Administration (FDA) has released its 2014 guidance agenda for its Center for Drug Evaluation and Research (CDER), listing dozens of guidance documents-some hotly anticipated-it plans to release during the 2014 calendar year.
Among the most notable guidance documents planned are related to FDA's regulation of advertising, and in particular social media. As Regulatory Focus reported last month, FDA said it would be releasing not one, but several social media guidance documents.
That move was apparently intended to allow for greater nuance, but also to satisfy congressional demands that social media guidance be issued within two years of the 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA).
FDA has now confirmed Focus' earlier reporting, listing three additional social media advertising guidances it plans to release:
In addition, FDA said it plans to release guidance documents on three other areas related to advertising:
FDA's guidance agenda also includes a number of other documents of interest to the industry.
One, Product Development Under the Animal Rule, relates to the development of products intended to treat or cure dangerous diseases or pathogens under FDA's Animal Efficacy Rule. That rule allows for some products to be approved based on safety data in humans and efficacy data exclusively from animals. The pathway has been already been used to develop products from botulism and anthrax.
FDA also has five guidance documents on biosimilars planned for this year-the most it has ever released in one year. They are as follows:
Other guidance of note include:
A complete listing of guidances may be found below.
Brief Summary and Adequate Information for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials including Submissions in Electronic Format
Direct-to-Consumer Television Advertisements - FDAAA DTC Television Pre-review Program
Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
Internet/Social Media Platforms: Correcting Independent-Third Party Misinformation About Prescription Drugs and Medical Devices
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices - Use of Links
Product Development Under the Animal Rule
Bioavailability and Bioequivalence Studies Submitted in NDA's or INDs for Orally Administered Drug Products - General Considerations
Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
Considerations in Demonstrating Interchangeability to a Reference Product
Labeling for Biosimilar Biological Products
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act
Allowable Excess Volume and Labeled Vial Fill Size
Analytical Procedures and Methods Validation for Drugs and Biologics
Appropriate Package Type Terms for Injection Drugs or Biological Products in Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers
Specified Biotechnology and Specified Synthetic Biological Products - Annual Report
Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
Evaluation of Near Infrared Spectroscopy (NIR) Methods
Immunogenicity- RelatedConsiderations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs
Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation
Attachment to Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment
Uncomplicated Gonorrhea: Developing Drugs for Treatment
Chronic Fatigue Syndrome/Myalgic Enephalomyelitis: Developing Drugs for Treatment
Common Issues in Drug Development for Rare Diseases
Developing Drug and Biological Products for Analgesic Indications
Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
Pregnant Women in Clinical Trials - Scientific and Ethical Considerations
Standards for Clinical Trial Imaging Endpoints
Upper Facial Lines: Developing Botulinum Toxin Products
Clinical Lactation Trials - Trial Design, Data Analysis and Recommendations for Labeling
General Clinical Pharmacology Considerations for Pediatrics Studies for Drugs and Biological Products
Pharmacokinetics During Pregnancy and the Postpartum Period - Trial Design, Data Analysis, and Impact on Dosing and Labeling
Multiple Endpoints in Clinical Trials
Contract Manufacturing Arrangements for Drugs: Quality Agreements
GXP Consideration for Outsourced IT (Cloud Computing) Systems in Medical Product Manufacturing and Clinical Study Environments
Interim Good Manufacturing Practice for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice
Submission of Field Alert Reports and Biological Product Deviation Reports
Best Practices in Developing Proprietary Names
Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act
Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen
Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A of the Federal, Food, Drug and Cosmetic Act
Providing Regulatory Submissions in Electronic Format - Manufacturing Establishment Information
Providing Regulatory Submissions in Electronic Format - Postmarketing Safety Reports
Providing Regulatory Submissions in Electronic Format - Standardized Study Data
Study Data Technical Conformance Guide and Data Standards Catalog
Adverse Events: Collection and Reporting for Secondary Endpoints
Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products - Content and Format
Labeling for Human Prescription Drug and Biological Products Approved Under Accelerated Approval
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
Pregnancy, Lactation, and Females and Males of Reproductive Potential: Labeling for Human Prescription Drug and Biological Products - Content and Format Requirements
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products - Content and Format
Applying the Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
Critical Path Innovation Meeting
Division of Good Clinical Practice Compliance (DGCPC) Requested Contents for New Drug and Biologic Applications to Facilitate BIMO Inspection Planning and Conduct
Drug Supply Chain Security Act (DSCSA) Implementation: Identification of Suspect Product and Termination of Notifications of Illegitimate Product for Finished Human Prescription Drugs
DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing of Finished Pharmaceuticals Drugs
Integrated Summary of Safety
Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
National Drug Code (NDC) Assignment of CDER-Regulated Products
Public Disclosure of FDA-Sponsored Studies
Reporting Drug Sample Distribution Under Section 6004 of the Affordable Care Act
Reporting Licensure by Wholesale Drug Distributor and Third-Party Logistic Providers
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs
Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
Use of a Master File for Shared System Risk Evaluation and Mitigation Strategies
User Fees for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal, Food, Drug and Cosmetic Act
Regulatory Focus newsletters
All the biggest regulatory news and happenings.