federal_register: 2014-22681

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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
2014-22681 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL52); Draft Guidance for Industry on Bioequivalence: Blood Level Bioequivalence Study; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #224) entitled "Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study" (VICH GL52). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products. 2014-09-24 2014 9 https://www.federalregister.gov/documents/2014/09/24/2014-22681/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary https://www.govinfo.gov/content/pkg/FR-2014-09-24/pdf/2014-22681.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #224) entitled "Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study" (VICH GL52). This draft guidance has been...  

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