FDA Must Act To Improve First-Review Cycle Approval Rates

 
• By Aidan Fry

Greater clarity in reviewers’ comments and limiting the effect of originators’ label changes on pending applications would help improve the rate of generic applications approved by the FDA on the first review cycle, a US government report proposes.

Cyclists
First-cycle review approvals of generics in the US must be approved, a government report suggests • Source: Shutterstock

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