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COVID-19 Supplement Approvals Jump, Some On-Time Decision Rates Slip For US FDA

 
• By Derrick Gingery

In FY '21 third quarter, on-time decision rate improved for generics and biosimilars, but dropped again for new drug applications.

On-Time flight board
The FDA made all biosimilar application decisions on time during the third quarter of FY 2021. • Source: Alamy

Generic and new drug application supplement work related to COVID-19 jumped during the third quarter of fiscal year 2021, although pandemic-related full ANDA approvals were on the decline.

The latest data on FDA efforts to approve applications related to the coronavirus pandemic indicated that ANDA supplement and NDA and BLA manufacturing supplement approvals increased 44% in FY 2021...

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