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Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn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