Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Draft Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA." This revised draft supersedes the draft guidance entitled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drug Products Submitted Under an ANDA," which was announced in the Federal Register on December 5, 2013. This revised draft guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
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