FDA brief: Week of Mar 14, 2016

FDA Voice

A ‘Roadmap’ for Navigating Patient Advocacy

By: John J. Whyte, M.D., M.P.H., Director of Professional Affairs and Stakeholder Engagement, CDER  

Help patient advocates gain a better understanding of FDA and ways to effectively advocate and engage with the Agency

  • Discussion on labeling, generic drugs, and providing input to FDA
  • Review programs including drug approval processes, expanded access, and FDA’s role in patient focused drug development (PFDD)



FDA and NIH Release a Draft Clinical Trial Protocol Template for Public Comment

By: Peter Marks, M.D., Ph.D., Director, CDER 

Key scientific priority to improve efficiency and save time/cost of clinical trials by  developing better organized, high-quality protocols

  • Clinical trial standards defined in:

International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 Good Clinical Practice: Consolidated Guidance (drugs)

International Organization for Standardization (ISO) Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice  ISO 14155:2011 (devices)

  • NIH-FDA Joint Leadership council launched project to develop a template for clinical trial protocol for IND (drug) and IDE (device) studies
  • FDA collaboration with industry groups like TransCelerate to help ensure consistency for the medical product development community
  • NIH and FDA are seeking public comment on the draft template (posted in blog)





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