federal_register: 2022-26414

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2022-26414 Statistical Approaches To Establishing Bioequivalence; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence." This draft guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. When finalized, this guidance will replace FDA's 2001 guidance for industry of the same name. 2022-12-05 2022 12 https://www.federalregister.gov/documents/2022/12/05/2022-26414/statistical-approaches-to-establishing-bioequivalence-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2022-12-05/pdf/2022-26414.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence." This draft guidance provides recommendations to sponsors and applicants...

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