When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities January 30, 2025 By Mark A. Tobolowsky & Charles G. Raver & James E. Valentine —

https://www.thefdalawblog.com/2025/01/when-is-a-confirmatory-trial-underway-or-conducted-with-due-diligence-enough-for-accelerated-approval-fda-explains-its-new-authorities/?utm_source=rss&utm_medium=rss&utm_campaign=when-is-a-confirmatory-trial-underway-or-conducted-with-due-diligence-enough-for-accelerated-approval-fda-explains-its-new-authorities