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Generic Drugs Drug Review Coronavirus COVID-19

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

  • Analysis

Executive Summary

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

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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