federal_register: E7-9556
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E7-9556 | Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Controlled Lists of Terms | Notice | The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled "Pharmacovigilance of Veterinary Medicinal Products: Controlled Lists of Terms." This draft guideline provides guidance for the development and maintenance of the controlled lists of terms required to complete the controlled data fields contained in adverse event reports concerning the use of veterinary medicinal products. Because the draft guideline applies to pharmacovigilance and adverse event reporting on veterinary vaccines regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on the scope of the guideline and its provisions so that we may include any relevant public input on the draft in the Agency's comments to the VICH Steering Committee. | 2007-05-18 | 2007 | 5 | https://www.federalregister.gov/documents/2007/05/18/E7-9556/draft-guidelines-on-pharmacovigilance-of-veterinary-medicinal-products-controlled-lists-of-terms | https://www.govinfo.gov/content/pkg/FR-2007-05-18/pdf/E7-9556.pdf | Agriculture Department; Animal and Plant Health Inspection Service | 12,22 | The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled "Pharmacovigilance of Veterinary Medicinal Products: Controlled Lists of... |