Use of Real-World Data and Real-World Evidence To Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #266 entitled "Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs." The draft guidance, if finalized, will describe FDA's current thinking with respect to assisting sponsors in incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies, and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).