Issue Date: May 6, 2011
Issued by: Center for Drug Evaluation and Research
Topic(s): Generic Drugs
Status: Final
Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications
This guidance is 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. 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.
Download the Guidance Document
