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Covis Pharma

http://covispharma.com

Latest From Covis Pharma

US FDA Advisory Committees As The Court Of Appeals

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.

Advisory Committees Drug Review

User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals

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.

User Fees Legislation

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.

Advisory Committees Review Pathway

Back To Normal-ish: What To Expect As Pharma Resumes In-Person Gatherings

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.

Generic Drugs Coronavirus COVID-19
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