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

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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #266 entitled "Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs." The guidance describes 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).