FDA Voice: Patient Advocacy Roadmap, FDA-NIH Template
FDA brief: Week of Mar 14, 2016
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
- Sponsoring daylong public workshop Navigating CDER: What You Should Know for Effective Engagement on March 31st
- 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)