federal_register: 2014-22450

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2014-22450 Bioequivalence Recommendations for Estradiol Vaginal Cream; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Draft Guidance on Estradiol." The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for estradiol vaginal cream. This draft guidance is a revised version of a previously issued draft guidance of the same subject. 2014-09-22 2014 9 https://www.federalregister.gov/documents/2014/09/22/2014-22450/bioequivalence-recommendations-for-estradiol-vaginal-cream-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2014-09-22/pdf/2014-22450.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Draft Guidance on Estradiol." The guidance provides specific recommendations on the design of bioequivalence (BE) studies to...

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