International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #259 entitled "Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV" (VICH GL58). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH draft guidance document is an annex to the VICH parent stability guidance, GFI #73/ VICH GL3(R), "Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)," and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application submitted within the regions in climatic zones III and IV.