Draft Guidance Defines Bioequivalence Data for ANDAs

The US Food and Drug Administration issued a Draft Guidance for Industry entitled Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDAs). Appearing in the Apr. 17 Federal Register, the draft guidance is meant to help ANDA applicants comply with a final rule published in January 2009, which requires the submission of all bioequivalence (BE) data obtained for preapproval and postapproval studies of generic-product formulations. Required data includes results from studies that fail to determine BE. This information is important to FDA because it “increases the agency’s knowledge and understanding of bioequivalence and generic drug development and promotes further development of science-based bioequivalence policies,” according to the Apr. 17 publication.

The new draft guidance includes: information on the types of ANDA submissions covered by the new BE final rule; a recommended format for summary reports of BE studies; and the types of formulations FDA considers to be the “same drug product formulation” for different dosage forms based on differences in composition. Definitions and details are provided for immediate-release and extended-release drug products, semisolid dosage forms, and complex dosage forms.

Comments on the draft guidance must be submitted by July 16, 2009, to the Division of Dockets Management (HFA–305), FDA, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or electronically at  www.regulations.gov.

Read the full draft guidance.