On July 27th, FDA released final guidance for Adaptive Designs for Medical Device Clinical Studies – a link to the guidance is here. According to Zachary Brennan in his article posted on RAPS, FDA received 151 comments from industry and most were included in the...
The FDA has been working to improve the process used by physicians to request Expanded Access — Compassionate Use to investigational drugs and biologics for their patients who need these therapies to stay alive. In a statement released in early June from FDA...
The Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on April 21st targeted for those new to the medical device industry or for those looking for a regulatory refresher. There will be multiple presentations including one from Gretchen Bowker...
Ed Miseta of Clinical Leader, recently wrote an excellent article about FDA’s pilot Clinical Outcome Assessment (COA) Compendium and hit on some good points about what you need to know about it. The FDA defines a COA as a “measure of a patient’s symptoms, overall...
Barbara D. Buch, M.D., Chair of the 907 Steering committee and the Associate Director for Medicine in FDA’s Center for Biologics Evaluation and Research, recently posted on FDA Voice her reflections on a focused action plan to support inclusion of diverse populations...
The House Appropriations Committee announced the Omnibus Appropriations bill providing the FDA and NIH more funds in the coming year. FDA will receive more funding in 2016 for: medical product safety initiatives Combating Antibiotic Resistant Bacteria (CARB)...