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

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

The coronavirus pandemic appears to be helping slow generic drug development, although the problem may not last long-term.

At the end of the first quarter of fiscal year 2021, the US Food and Drug Administration reported 184 ANDAs...

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