federal_register: 2014-28830

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-28830 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #214) entitled "Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data" (VICH GL35). 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 provide recommended standards to construct a single Adverse Event Report (AER) electronic message to transmit VICH GL42 contents to all member regions and Product Problem Reports (PPR) to FDA for veterinary medicinal products. Please note that VICH GL42 has been harmonized in GFI #188, "Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine." 2014-12-10 2014 12 https://www.federalregister.gov/documents/2014/12/10/2014-28830/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary https://www.govinfo.gov/content/pkg/FR-2014-12-10/pdf/2014-28830.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #214) entitled "Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data" (VICH GL35). This guidance has been...

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