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US FDA's On-Time Review Decision Rates Slip During The Pandemic, Especially For Biosimilars

 
• By Derrick Gingery

Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.

Dam leaking
Is the dam starting to crack in the US FDA's pandemic review performance? • Source: Shutterstock

The US Food and Drug Administration’s biosimilar approvals appear to be the agency operation that is suffering the most under the strain of the coronavirus pandemic, but the FDA argues the drop in on-time actions is a function of the program’s relatively small sample size, not an inherent performance problem.

But with review timeliness also slipping a bit for the prescription and generic drug user fee programs over the last...

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