federal_register: 2015-27816

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-27816 Bioequivalence Recommendations for Progesterone; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on progesterone gel entitled "Draft Guidance on Progesterone." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for progesterone gel. 2015-11-02 2015 11 https://www.federalregister.gov/documents/2015/11/02/2015-27816/bioequivalence-recommendations-for-progesterone-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2015-11-02/pdf/2015-27816.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on progesterone gel entitled "Draft Guidance on Progesterone." The recommendations provide specific guidance on the design of...  

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