FDA Issues Guidance for Bioequivalency Data for ANDAs

May 6, 2011

The U.S. Food and Drug Administration (FDA) has issued guidance intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) in complying with FDA’s requirements for the submission of bioequivalence (BE) data. FDA’s final rule on “Requirements for Submission of Bioequivalence Data” (the BE data rule) requires an ANDA applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval, including studies that do not demonstrate that the generic product meets the current bioequivalence criteria.2 All BE studies conducted on the same drug product formulation must be submitted to the Agency as either a complete study report or a summary report of the BE data.3 The amended regulations include a definition of same drug product formulation (section 320.1(g)).

To view the guidance document: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM134846.pdf