Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
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.