WASHINGTON, June 5 -- Food and Drug Administration has issued a notice called: Raw Data for Safety and Effectiveness Studies; Guidance for Industry; Availability.
The notice was published in the Federal Register on June 5 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM) review of safety and effectiveness studies submitted in support of new animal drug applications. This gu...