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Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half

 
• By Bridget Silverman

With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.

FDA first-half plunge
APPROVALS HAVE TAKEN A DIVE IN THE FIRST HALF OF THE YEAR, BUT SECOND-HALF NUMBERS TEND TO BE HIGHER. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Only half of the novel agents with user fee goal dates in the first half of 2022 received approval letters from the US FDA, reflecting a steep acceleration in a multi-year trend toward greater use of complete response letters.

The US FDA approved 19 novel agents during the first half of 2022 while issuing at least 14 complete response letters, according the

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