federal_register: 2016-20146

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2016-20146 Bioequivalence Recommendations for Fidaxomicin; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on generic fidaxomicin tablets entitled "Draft Guidance on Fidaxomicin." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fidaxomicin tablets. 2016-08-24 2016 8 https://www.federalregister.gov/documents/2016/08/24/2016-20146/bioequivalence-recommendations-for-fidaxomicin-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2016-08-24/pdf/2016-20146.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on generic fidaxomicin tablets entitled "Draft Guidance on Fidaxomicin." The recommendations provide specific guidance on the design of...

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