CDER's 2014 Guidance Agenda Shows Heavy Focus on Social Media, Biosimilars Guidance

Posted 03 February 2014 By Alexander Gaffney, RAC

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.

Heavy Focus on Advertising

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:

  • 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

In addition, FDA said it plans to release guidance documents on three other areas related to advertising:

  • 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

Other Guidances of Interest

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:

  • 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

Other guidance of note include:

  • Guidance specifically on chronic fatigue syndrome
  • Guidance on Risk Evaluation and Mitigation Strategies (REMS)
  • A special guidance attachment on developing antiviral products for HIV drugs
  • A guidance for addressing "common issues in drug development for rare diseases,"
  • Guidance on the use of multiple endpoints in clinical trials
  • Compounding guidances on outsourcing facilities used in pharmaceutical compounding
  • Guidance on developing proprietary names for drugs
  • Implementing the Drug Supply Chain Security Act

A complete listing of guidances may be found below.

CDER 2014 Guidance Agenda

CATEGORY -Advertising

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

CATEGORY - Animal Rule

Product Development Under the Animal Rule

CATEGORY - Biopharmaceutics

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

CATEGORY - Biosimilarity

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

CATEGORY -Chemistry

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

CATEGORY -Clinical/Antimicrobial

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

CATEGORY -Clinical/Medical

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

CATEGORY -Clinical Pharmacology

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

CATEGORY -Clinical/Statistical

Multiple Endpoints in Clinical Trials

CATEGORY -Quality: Facility, Production and Process Control

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

CATEGORY -Drug Safety

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

CATEGORY -Electronic Submissions

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

CATEGORY -IND

Adverse Events: Collection and Reporting for Secondary Endpoints

CATEGORY -Labeling

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

CATEGORY -Procedural

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

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