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Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA

On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA that was issued in December 2013.

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 and is 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.

This guidance will clarify the agency’s recommendations regarding BE information submitted in an ANDA submission and will provide assistance to potential ANDA applicants, and support access for patients to lower-cost, high-quality medicines.

Also, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA.

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.



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