federal_register: 2011-28371
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-28371 | Revised Guidance for Industry on Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision), VICH GL18(R); Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (<greek-i>100) entitled "Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision)" VICH GL18(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The guidance is intended to recommend acceptable amounts of residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in this guidance) for the safety of the target animal as well as for the safety of human consumers of products derived from treated food producing animals. It is intended to assist in developing new animal drug applications (referred to as marketing applications in this guidance) submitted to the European Union, Japan, and the United States. | 2011-11-02 | 2011 | 11 | https://www.federalregister.gov/documents/2011/11/02/2011-28371/revised-guidance-for-industry-on-impurities-residual-solvents-in-new-veterinary-medicinal-products | https://www.govinfo.gov/content/pkg/FR-2011-11-02/pdf/2011-28371.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (<greek-i>100) entitled "Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision)" VICH... |