Zdrowie i gospodarka · 1.09.2015
Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #227 entitled "Two- Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections." The guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions to the Center of Veterinary Medicine (CVM) to support approval of a new animal drug or abbreviated new animal drug.