FDA Guidance on Adaptive Designs released

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...

Latest updates on Compassionate Use

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...

Buch updates on FDA’s progress made for clinical trials

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...