federal_register: 2010-20235
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-20235 | Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R); Request for Comments; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (<greek-i>100) entitled "Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R)." This draft revised guidance, which updates a final guidance on the same topic for which a notice of availability was published in the Federal Register of May 22, 2001 (66 FR 28182) (the 2001 final 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. | 2010-08-17 | 2010 | 8 | https://www.federalregister.gov/documents/2010/08/17/2010-20235/draft-revised-guidance-for-industry-on-residual-solvents-in-new-veterinary-medicinal-products-active | https://www.govinfo.gov/content/pkg/FR-2010-08-17/pdf/2010-20235.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (<greek-i>100) entitled "Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision)... |