💰FY 2026 Animal Generic Drug User Fee Rates and Procedures
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2026 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINADs), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2026.
Learn More📋FDA Releases Guidance on Raw Data Submission for Animal Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.
Learn More🐾Second Annual Animal Drug User Fee Educational Conference Announcement
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following educational conference (public meeting) entitled "Second Annual Animal Drug User Fee Educational Conference." This is the second of five annual educational conferences FDA will host as described in the "Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028." The purpose of this series of conferences is to provide educational sessions for stakeholders who are interested in the new animal drug approval process.
Learn More🐾FDA Final Rule on New Animal Drug Regulations Effective May 2025
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
Learn More⚖️DEA Revocation Order Impacting Texas Veterinarian Registration
The Drug Enforcement Administration (DEA) has issued a final order revoking the registration of Linwood A. Starks, D.V.M., due to his inability to practice veterinary medicine in Texas. The decision is based on the registrant's default following a suspension of his state veterinary license, highlighting the importance of state authority in maintaining a DEA registration for handling controlled substances.
Learn More🐾New Animal Drug Regulations Affecting Compliance and Approval Processes
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2024. The animal drug regulations are also being amended to improve their accuracy and readability.
Learn More🐾FDA Seeks Input on Cannabis-Derived Products in Veterinary Use
The Food and Drug Administration (FDA, the Agency, or we) is soliciting comments from the public, particularly veterinarians, related to the use of cannabis-derived products (CDPs) in animals, with an emphasis on cannabidiol (CBD) products and general trends associated with those products, including information about: usage trends (e.g., product selection, indications, etc.), quality standards, benefits of use, potential drug interactions, adverse events and safety problems, and toxicological concerns. This information will enhance the Center for Veterinary Medicine's (CVM's) knowledge of potential safety signals associated with these products, in addition to aiding our understanding of veterinarians' experiences related to the use of CDPs for their animal patients.
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