Federal Register #FDA-2013-D-1464

FDA Final Guidance on Bioequivalence Studies for ANDA Drugs

The Food and Drug Administration (FDA) has issued a final guidance document for industry regarding bioequivalence studies for drugs submitted under an Abbreviated New Drug Application (ANDA). - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - No OEMs or vendors are mentioned, as this is a policy guidance document and not a procurement opportunity. - No products or services are being requested; the notice is informational only. - The guidance provides recommendations for: - Conducting bioequivalence (BE) studies with pharmacokinetic endpoints - Drugs submitted under ANDAs, including amendments and supplements - Immediate-release and modified-release oral dosage forms - Certain non-orally administered drug products (e.g., transdermal, rectal, nasal) where systemic exposure is appropriate for BE - The document finalizes and updates previous draft guidance, clarifying requirements for industry stakeholders. - No purchase quantities, part numbers, or unique procurement requirements are included.

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry titled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA." This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements. It describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act and FDA regulations. The guidance finalizes the draft guidance issued on August 23, 2021, and is applicable to immediate-release and modified-release oral dosage forms, as well as certain non-orally administered drug products.

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