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Failed ANDA Bioequivalence Studies Haven’t Impacted Review Decisions, FDA Says

Executive Summary

Bioequivalent studies that fail to show bioequivalence between a generic drug and its reference product have not been a factor in ANDA approvals, Barbara Davit, acting director of the Office of Generic Drugs’ Division of Bioequivalence 2, reported at the Generic Pharmaceuticals Association’s fall technical meeting on Oct. 5 in Bethesda, Md.

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