# Requirements for Submission of Bioequivalence Data; Final Rule
> **Food and Drug Administration** · Final rule. · Published 2009-01-16 · Effective 2009-07-15 · 74 FR 2849
## Document
- **Document number:** E9-884
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 2849
- **CFR reference:** 21 CFR 314
- **Publication date:** 2009-01-16
- **Effective date:** 2009-07-15
- **HHS docket:** Docket No. FDA-2003-N-0209
## Abstract

The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because we now believe that data from additional BE studies may be important in our determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD), and are relevant to our evaluation of ANDAs in general. In addition, such data will increase our understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/01/16/E9-884/requirements-for-submission-of-bioequivalence-data-final-rule)
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