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40+ Candidates Give US FDA Plenty Of Latitude While Growing 2023 Novel Approval Count From 2022

 
• By Bridget Silverman

User fee goal dates in the second half of 2023 suggest cancer and breakthrough therapy approvals should recover from first-half dips and a resumption of inspections in China could revive COVID-delayed products.

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August could be busy for the FDA with action expected on multiple novel product applications. • Source: Shutterstock

The US Food and Drug Administration only needs to approve 10 more novel agents by year-end to match its 2022 count of 45, a number that looks more than feasible given the 40 user fee goal dates for novel candidates coming up in the second half of 2023.

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