Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Company explored ‘a number of paths to approval’ with agency, but modest progression-free survival benefit in monotherapy treatment of NRAS-mutant melanoma appears to have doomed the new drug application, which was pulled less than two weeks before advisory committee review.
CDER schedules an NDAC and DSRMAC joint meeting while also negotiating with industry stakeholders on a potential proposal for a user fee program to support FDA’s work on finalizing monographs or amending monographs with additional ingredients or indications.
With price controls in Medicare looming nine years after approval, launch strategies such as ‘bridge’ programs that build initial volume with free drug may have to be adjusted.