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Consistency, Not Fireworks: US FDA’s Novel Approvals Times Stick Close To PDUFA Schedule

 
• By Bridget Silverman

CDER holds steady with a median time to approval of 11 months, while CBER posts 10.5 month median review time for its largest novel approvals class.

Fireworks-with-banned-symbol
• Source: Shutterstock

The sheer number of US FDA’s novel drug approvals in 2023 contrasts with the generally moderate, steady performance of the Center for Drug Evaluation and Research over the year, including a median review time of 11 months that matched 2022.

The 55 new molecular entities and novel biologics approved last year break down into 33 applications reviewed under priority review and 22 that received standard review

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