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FDA Takes Cues From Feedback On GDUFA Research Priorities

Agency Announces Science And Research Priority Initiatives For FY2022

Executive Summary

The FDA has outlined how it has incorporated feedback on its GDUFA science and research priorities for FY2022 from a public workshop held earlier this year, across issues including harmonization of bioequivalence standards, nitrosamine impurities, and the use of AI to support generic drug development.

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