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GUIDANCE DOCUMENT

Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications May 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0126
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0126.

 
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