USA – FDA refreshes bioequivalence guidance for generic drugs

Generic drug makers received a refreshed draft guidance from the US Food and Drug Administration on Friday; the guidance updates some recommendations on the conduct of bioequivalence (BE) studies that have pharmacokinetic endpoints.

In announcing the updated draft guidance’s availability, FDA said that the document is meant to « clarify the agency’s recommendations regarding BE information submitted in an [abbreviated new drug application] submission, provide assistance to potential ANDA applicants, and support access for patients to lower cost, high quality medicines.” The new revision updated a draft originally published in December 2013. (RELATEDFDA Updates Bioequivalence Testing Guidance Intended for Generic Drug Manufacturers, Regulatory Focus 04 December 2013)

Applicants who are planning an abbreviated new drug application (ANDA) submission should also consult relevant product-specific guidances for detailed information about which BE studies should be completed as part of the submission process, noted FDA…