Pink Sheet Podcast: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials
Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.
You may also be interested in...
Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’