federal_register: E6-445
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E6-445 | Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (VICH Topic GL24) and Data Elements for Submission of Adverse Event Reports (VICH Topic GL42) | Notice | The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed two draft guidelines titled "Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports" and "Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports." These draft guidelines describe, respectively, standardized terminology for the identification of possible adverse events following the use of veterinary medicinal products, and the specific data elements to be used for the submission and exchange of spontaneous adverse event reports between marketing authorization holders (licensees/permittees) and regulatory authorities. Because the draft guidelines apply 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 each guideline and its provisions so that we may include any relevant public input on the drafts in the Agency's comments to the VICH Steering Committee. | 2006-01-18 | 2006 | 1 | https://www.federalregister.gov/documents/2006/01/18/E6-445/draft-guidelines-on-pharmacovigilance-of-veterinary-medicinal-products-management-of-adverse-event | https://www.govinfo.gov/content/pkg/FR-2006-01-18/pdf/E6-445.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 two draft guidelines titled "Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse... |