FDA’s Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request for Comments

The ANIMAL HEALTH INSTITUTE (AHI) and the GENERIC ANIMAL DRUG ALLIANCE (GADA) appreciate the opportunity to comment on the evaluation of approaches to demonstrate effectiveness of heartworm preventatives in dogs. AHI and GADA are the national trade organizations representing pioneer and generic manufacturers of animal health products the pharmaceuticals, vaccines and feed additives used in modern food production, and the medicines that keep livestock and pets healthy. The animal health industry is committed to bringing innovative, safe and effective products to market. Attached we have provided answers to the ten questions posed by the Center for Veterinary Medicine regarding possible alternative approaches for evaluating heartworm preventatives. Thank you for your consideration of these comments.