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The U.S. Food and Drug Administration today issued draft guidance to provide recommendations to assist sponsors in developing proprietary names for new animal drugs in order to avoid contributing to medication errors,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Draft Guidance for Industry #240, entitled "Proprietary Names for New Animal Drugs," proposes a framework for evaluating proposed proprietary names before submitting them for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 The draft guidance also explains how new animal drug sponsors can request agency evaluation of a proposed proprietary name.

Read entire press release.

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