ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19

 
• By Derrick Gingery

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

Bottle of generic drugs
FDA ANDA approvals were ahead of their FY 2020 pace in the first quarter of FY 2021. • Source: Shutterstock

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