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ビジネス · 2026/5/291 分で読めます
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability
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概要
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA." This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, 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. This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021.
情報源の原言語: Federal Register — Health and Human Services原文の発表を開く →