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Latest From Covis Pharma
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.
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.
With the mask mandate now lifted for air travel and the grimmer milestone of one million Americans dead from COVID approaching, the Pink Sheet looks back at the generic trade association’s annual meeting to see what business gatherings may look like going forward.