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FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
FDA announced the availability of a draft guidance, “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA,” on August 20, 2021, which provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. Specifically, the guidance:
In general, applicants for ANDAs must use an approach that is the most accurate, sensitive, and reproducible, according to the draft guidance. The draft guidance also says that in-vivo and/or in-vitro methods can be used to establish BE. Specifically, the draft guidance covers: