1. Pink Sheet

US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19

 
• By Bridget Silverman

CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.

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• Source: Shutterstock

Possibly the most surprising aspect of the US FDA’s novel approvals in 2023 is a steep jump in what has been one of the most stable review metrics for more than a decade: how many times the FDA missed Prescription Drug User Fee Act user fee goal dates for novel approvals.

The Center for Drug Evaluation and Research approved six novel agents after their user fee goal dates had passed, representing...

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