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‘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

The US Food and Drug Administration missed its on-time generic drug application action commitment during the second fiscal quarter, but the agency expects to be able to use a relatively new accounting technique to get the number officially above water once a few pending applications are adjudicated.

The on-time action rate for original applications in the GDUFA program slipped again during the January-March 2021 period to 89%, the third consecutive quarter where a decline was reported, according...

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