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Guidance Issuing OfficeCenter for Veterinary Medicine
The recommended approach to demonstrate substantial evidence of effectiveness of an investigational new animal drug intended for the prevention of heartworm disease in dogs is for the sponsor to conduct two laboratory dose confirmation studies and one multi-site field effectiveness study in accordance with the principles of Good Clinical Practice (GCP) as described in GFI #85 (VICH GL9), “Good Clinical Practice.’’ Laboratory dose confirmation studies are experimentally-induced infection studies that provide known exposure to infectious Dirofilaria immitis (D. immitis) larvae (L3) due to contemporaneous experimental infection of the same number of L3 to negative control dogs and dogs administered the investigational new animal drug. Laboratory dose confirmation studies also allow for quantitative evaluation of outcome by determining the presence of adult worms as well as the individual worm burden in each dog.
The field effectiveness study evaluates the effectiveness of the investigational new animal drug under actual conditions of use in client-owned dogs and with the current enzootic status, ecologic, and genetic factors affecting heartworm disease in dogs in each location.
FDA’s recommended approach considers the laboratory dose confirmation studies and the field effectiveness study together when evaluating if substantial evidence of effectiveness (21 CFR 514.4) and inferential value to the target population have been met.