The US Food and Drug Administration (FDA) has issued four final guidance documents to promote innovative approaches to animal drug development:
- Final guidance for industry (GFI) #265, “Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs”;
- Final guidance for industry (GFI) #266, “Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs”;
- Final guidance for industry (GFI) #267, “Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs”; and,
- Final guidance for industry (GFI) #268, “Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.”
The FDA received comments on the draft guidance documents and those comments were considered as the guidances were finalized. Editorial changes were also made to the final versions to improve clarity.
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