If your email program has trouble displaying this email, view as a webpage. FDA Issues Final Guidance on Expanded Conditional Approval for Certain Animal Drugs On July 13, 2021, the FDA issued final Guidance for Industry (GFI) #261, entitled "Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs," for public comment. The agency received three comments on the draft guidance, which was finalized with limited clarifying changes. In 2018, as part of the reauthorization of FDA's Animal Drug User Fee Act (ADUFA) program, Congress amended section 571 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expand FDA's authority to grant conditional approval to include certain animal drugs for use in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) for diseases or conditions that would not be eligible for conditional approval under the MUMS provisions of the FD&C Act. The agency then issued GFI #261 in draft form less than 12 months later. In January 2021, the FDA announced the conditional approval of KBroVet-CA1 (potassium bromide chewable tablets), the first drug to receive conditional approval through the expanded pathway. The agency looks forward to evaluating additional applications under the expanded conditional approval pathway prior to the sunset of the program in 2028. You are subscribed to updates from FDA's Center for Veterinary Medicine.

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