Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #268 entitled "Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs." The guidance describes FDA's current thinking with respect to assisting sponsors in incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).