federal_register: 2013-07296

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2013-07296 Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Metronidazole Vaginal Gel." The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for metronidazole vaginal gel. 2013-03-29 2013 3 https://www.federalregister.gov/documents/2013/03/29/2013-07296/draft-guidance-for-industry-on-bioequivalence-recommendations-for-metronidazole-vaginal-gel https://www.govinfo.gov/content/pkg/FR-2013-03-29/pdf/2013-07296.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Metronidazole Vaginal Gel." The guidance provides specific recommendations on the design of...

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