Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request for Comments

摘要

The Food and Drug Administration (FDA or we) is evaluating its current thinking regarding the design of studies intended to generate data to support substantial evidence of effectiveness for investigational new animal drugs intended for the prevention of heartworm disease in dogs. We are specifically requesting public input on possible alternative approaches for evaluating such products or information to assist in the potential development of alternative recommended study designs.