federal_register: 00-2379
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-2379 | Draft Guideline on Stability Testing of Biotechnological/Biological Veterinary Medicinal Products, VICH Topic GL17 | Notice | A draft guideline titled "Stability Testing of Biotechnological/Biological Veterinary Medicinal Products" has been developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The guideline contains proposed international standards for the generation and submission of stability data for products such as cytokines (interferons, interleukins, colony- stimulating factors, tumor necrosis factors), monoclonal antibodies, and vaccines consisting of well-characterized proteins or polypeptides, including some conventional vaccines. Because the draft guidelines pertain to veterinary biological products regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on its provisions so that we may include any relevant public input on the draft in the Agency's comments to the VICH Steering Committee. | 2000-02-03 | 2000 | 2 | https://www.federalregister.gov/documents/2000/02/03/00-2379/draft-guideline-on-stability-testing-of-biotechnologicalbiological-veterinary-medicinal-products | https://www.govinfo.gov/content/pkg/FR-2000-02-03/pdf/00-2379.pdf | Agriculture Department; Animal and Plant Health Inspection Service | 12,22 | A draft guideline titled "Stability Testing of Biotechnological/Biological Veterinary Medicinal Products" has been developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products... |