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...

Empowered Patients in Clinical Trials

Reading an article by Ed Miseta, Clinical Leader, brought to mind the importance of the balance of patient’s needs and scientific advancement.  Miseta’s article shared comments from leaders in Pharma where empowered patients and their community voice is recognized and...