federal_register: E7-22901

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E7-22901 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revision); Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (<greek-i>93) entitled "Impurities in New Veterinary Medicinal Products (Revision)" VICH GL11(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). This revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products. 2007-11-23 2007 11 https://www.federalregister.gov/documents/2007/11/23/E7-22901/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary https://www.govinfo.gov/content/pkg/FR-2007-11-23/pdf/E7-22901.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>93) entitled "Impurities in New Veterinary Medicinal Products (Revision)" VICH GL11(R). This revised guidance has been developed for...

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