CDER House Rules

  • by: |
  • 01/25/2016

The recent mega-storm allowed many of us drugwonks to curl up with a new work of action non-fiction … from the FDA:

Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016

It’s worth perusing in its entirety, but here are a few items to tickle your regulatory palate:

For those of you following the debate over off-label communications

Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Licensed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices

The New Gold Standard

Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft

Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products

Multiple Endpoints in Clinical Trials

The broader sharing of pharmacoecomonic data

Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act

And the continuing saga of “Emerging Electronic Media” (aka: “Social Media”)

Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites

The evolution of discussing risk information

Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft

For the Biosimilar Brotherhood, three things to consider

Considerations in Demonstrating Interchangeability With a Reference Product

Labeling for Biosimilar Products

Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

Attention NORD Horde

Guidance for clinical Investigators and Sponsors Natural History Studies for Rare Disease Drug Development

Women and Children First?

Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments

Pediatric Oncology Product Development; Revised Draft

Pregnant Women in Clinical Trials – Scientific and Ethical Considerations

Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling; Revised Draft

Phase Fore!

Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines

REMS Assessment: Planning and Reporting

Waxing Generic

Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines

Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn

General Principles for Evaluating Abuse - Deterrent Properties of Generic Solid Oral Opioid Drug Products

What’s on CDER’s list is interesting … as well as what is not.

2016 is going to be an interesting year.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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