federal_register: 2016-30309
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-30309 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bioequivalence: Blood Level Bioequivalence Study; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry (GFI) #224 entitled "Bioequivalence: Blood Level Bioequivalence Study" (VICH GL52). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products. | 2016-12-16 | 2016 | 12 | https://www.federalregister.gov/documents/2016/12/16/2016-30309/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary | https://www.govinfo.gov/content/pkg/FR-2016-12-16/pdf/2016-30309.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 guidance for industry (GFI) #224 entitled "Bioequivalence: Blood Level Bioequivalence Study" (VICH GL52). This guidance has been developed for veterinary use by the... |