Makena Accelerated Approval Hearing Will Be Virtual, Likely In September Or October
Presiding officer Celia Witten denies Covis’ request for an in-person hearing, saying it is unclear at this time how COVID would affect a proceeding in the fall. Hearing agenda spans two-and-a-half days and is modeled, in part, on the Avastin hearing, but with twice the time for public comment.
You may also be interested in...
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.
Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.
US FDA’s advisory committee members question when it will be clear current vaccines are not providing sufficient protection and express concern about the time it will take to change their composition given the need for clinical data to gain authorization.