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A Standard September Ahead Thanks To Light US FDA User Fee Calendar With Few Expedited Reviews

 
• By Bridget Silverman

Twelve applications with September goal dates include six novel agents but only one breakthrough designation.

School buses
The bus is empty; FDA's user fee calendar is only slightly more full. • Source: Shutterstock

The most unusual aspect of the dozen applications with September 2023 goal dates at the US FDA is how unusual they aren’t. Standard reviews are the rule, even for the lone breakthrough therapy-designated NDA.

Six novel agents are among the September goal dates, along with four 505(b)(2) NDAs. A new formulation and a significant new indication round out the PDUFA calendar

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