Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry

On 8 December 2020 the FDA Announced the Availability of the Draft Guidance for Industry.

FDA is issuing this guidance to help sponsors of human nonprescription 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 available to sponsors to use for nonprescription drug products before a product bearing that proprietary name is marketed. This guidance does not address the designation of established names or proper names.

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