federal_register: E8-29692

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E8-29692 Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendation for Vancomycin HCl." The recommendation provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules. 2008-12-16 2008 12 https://www.federalregister.gov/documents/2008/12/16/E8-29692/draft-guidance-for-industry-on-bioequivalence-recommendation-for-vancomycin-hcl-availability https://www.govinfo.gov/content/pkg/FR-2008-12-16/pdf/E8-29692.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendation for Vancomycin HCl." The recommendation provides specific guidance on the design of bioequivalence (BE)...

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