Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies."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's) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.
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