Aug. 20, 2021

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FDA publishes revised draft guidance for industry, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

On August 20, 2021, FDA published a revision to the draft guidance for industry Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. This guidance provides recommendations to applicants planning abbreviated new drug application (ANDAs) submissions. Specifically, this guidance includes recommendations on how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic (FD&C) Act and FDA regulations. This guidance is generally applicable to dosage forms intended for oral administration and to non-orally administered drug products in which reliance on systemic exposure measures is suitable for establishing BE (e.g., transdermal delivery systems and certain rectal and nasal drug products). This guidance will also be useful to applicants planning BE studies intended to be conducted during the post-approval period for changes to a drug product approved under an ANDA.

As part of the Drug Competition Action Plan, the FDA is publishing this guidance to clarify the agency’s recommendations regarding BE information submitted in an ANDA submission, provide assistance to potential ANDA applicants, and support access for patients to lower cost, high quality medicines.

This draft guidance revises the draft guidance that was issued in December 2013 and, when finalized, will represent the current thinking of the FDA on this topic. In addition to this draft guidance, FDA also recommends that ANDA applicants consult routinely published product-specific guidances (PSGs) when considering the appropriate BE study and/or other studies for a proposed generic product. For more information about FDA’s PSG publications and to search for the most recent version of a PSG, see the Product-Specific Guidances for Generic Drug Development web page. 

FDA is publishing this revised draft guidance to solicit public comments on the topics discussed in the guidance. You may submit your comments to the revised draft guidance to Docket FDA-2013-D-1464 on regulations.gov. FDA will consider all comments carefully when finalizing these recommendations. 

FDA recommends that applicants intending to submit investigational new drug applications, new drug applications, and new drug application supplements consult the draft guidance for industry Bioavailability Studies Submitted in NDAs or INDs — General Considerations (February 2019), which addresses bioavailability studies for these submission types. When finalized, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs