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The FDA guidance was issued to help sponsors of human prescription drug products develop proprietary names for those products. This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations.
It also describes the framework FDA uses in evaluating proposed proprietary names that is also available to sponsors to use before submitting names for FDA review if they wish. This guidance does not address the designation of established names or proper names.
This guidance applies to all human prescription drug products.