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
Friday, March 9, 2018
FDA Issues Guidance on Proprietary Names for New Animal Drugs
The U.S. Food and Drug Administration today issued draft guidance to provide recommendations to assist sponsors in developing proprietary names for new animal drugs in order to avoid contributing to medication errors, negatively impacting safe use of the drug, or misbranding the drug.
Draft Guidance for Industry #240, entitled "Proprietary Names for New Animal Drugs," proposes a framework for evaluating proposed proprietary names before submitting them for review by the FDA’s Center for Veterinary Medicine. The draft guidance also explains how new animal drug sponsors can request agency evaluation of a proposed proprietary name.