Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
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Food and Drug Administration and Compliance Issues
Thursday, September 26, 2019
FDA Issues Draft Guidance on Expanded Conditional Approval for Certain Animal Drugs
The U.S. Food and Drug Administration today released draft Guidance for Industry, entitled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs,” to assist animal drug sponsors and potential sponsors who may be interested in pursuing conditional approval to market animal drugs to address serious or life-threatening diseases or conditions, or an unmet animal or human health need, and for which demonstrating effectiveness would require complex or particularly difficult study or studies.
Until recently, only new animal drugs intended for minor use in major species or for use in a minor species (MUMS) were eligible for conditional approval. 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.
Expanded conditional approval has the potential to incentivize drug development and provide veterinarians with legally marketed new animal drugs to treat serious or life-threatening diseases or conditions and to fill treatment gaps where currently no therapies are available.