‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively

 
• By Derrick Gingery

ANDA action rate dipped below the 90% mandate in second fiscal quarter, another illustration of the effect the pandemic and other issues have on US FDA’s generic drug assessment system.

Generic drug pills
The falling on-time action rate for generic drug applications could be a concern for sponsors. • Source: Alamy

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