Zdrowie i gospodarka · 10/01/2006

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revised); Request for Comments; Availability

The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry ( 93) entitled "Impurities in New Veterinary Medicinal Products (Revised)" VICH GL11(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). This draft 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.