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# Generic Drug Bioequivalence Study MAPP
- URL: https://www.fdaweb.com/generic-drug-bioequivalence-study-mapp/
- Published: 2017-06-22T12:00:00.000Z
- Updated: 2026-09-14T22:30:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139008

CDER has issued a Manual of Policies and Procedures (MAPP) describing Office of Generic Drugs policies and procedures for reviewing bioequivalence studies with clinical endpoints submitted in ANDAs. The [document](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM079585.pdf?ref=fdaweb.com) says before 2000, all comparative clinical endpoint studies submitted in ANDAs were referred to the appropriate Office of New Drugs review divisions for review. Currently, however, the Office of Generic Drugs’ Office of Bioequivalence Division of Clinical Review reviews bioequivalence studies with clinical endpoints.

The policy is that the Division of Clinical Review performs the review of bioequivalence studies with clinical endpoints submitted in ANDAs and may consult with other offices and/or Centers in cases where special expertise is required.