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CDER Midyear Report: Sponsors Struggle With Drop In Novel Approval Rate

 
• By Michael Cipriano

CDER has approved only 13 novel products in the first half of 2019 while issuing at least seven such CRLs during that timeframe. The sparse approval landscape more so resembles that of 2016 compared with the banner years of 2017 and 2018.

Sponsors haven't been as successful in 2019 in getting novel product approvals.

A complete response letter (CRL) for Acer Therapeutics Inc.'s vascular Ehlers-Danlos syndrome candidate Edsivo (celiprolol) capped off a relatively difficult first half of 2019 for novel drugs and biologics under review at the US Food and Drug Administration.

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