federal_register: E5-8222
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E5-8222 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision); 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>92) entitled "Impurities in New Veterinary Drug Substances (Revision)" VICH GL10(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 July 7, 2000 (the 2000 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The draft revised document is intended to provide guidance for registration applicants on the content and qualification of impurities in new veterinary drug substances produced by chemical syntheses and not previously registered in a country, region, or member state. | 2006-01-04 | 2006 | 1 | https://www.federalregister.gov/documents/2006/01/04/E5-8222/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary | https://www.govinfo.gov/content/pkg/FR-2006-01-04/pdf/E5-8222.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>92) entitled "Impurities in New Veterinary Drug Substances (Revision)" VICH GL10(R). This draft revised guidance,... |