FDA Announces Final Guidance for Heartworm Disease Prevention Products for Dogs

On June 25, 2024, the FDA announced the availability of final guidance for industry (GFI) #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The FDA received eight comment submissions on the draft guidance, and all comments were considered as the guidance was finalized.

In the final guidance, the FDA clarified the discussion and recommendations related to geographic locations, laboratory dose confirmation studies, and field effectiveness studies. The agency also clarified that the recommendations in this guidance are based on current technology and veterinary epidemiology, including available diagnostic methodologies. Individuals are encouraged to discuss deviations from these recommendations with the FDA, especially as advances in veterinary medicine related to heartworm disease, including disease epidemiology, isolate characterization, or diagnostic testing are identified. The guidance announced in this notice finalizes the draft guidance dated November 30, 2022.