federal_register: 2011-23605

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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
2011-23605 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (<greek-i>214) entitled "Draft Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data" (VICH GL35). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal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 provide recommended standards to construct a single electronic message to transmit data elements for submission of adverse event reports (AERs) to all member regions. 2011-09-15 2011 9 https://www.federalregister.gov/documents/2011/09/15/2011-23605/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary https://www.govinfo.gov/content/pkg/FR-2011-09-15/pdf/2011-23605.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (<greek-i>214) entitled "Draft Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data"...  

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