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Wednesday, May 23, 2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs


The Food and Drug Administration announced today that the Center for Veterinary Medicine (CVM) is evaluating the design of studies intended to support the standard of substantial evidence of effectiveness for new animal drugs to prevent heartworm disease in dogs. Currently, there are gaps in knowledge that prevent the FDA from fully evaluating which alternative approaches are suitable for meeting the standards of effectiveness. The need to evaluate alternative approaches is emphasized by the evolving susceptibility of Dirofilaria immitis larvae to heartworm preventatives containing macrocyclic lactones.

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