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GUIDANCE DOCUMENT

Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry Guidance for Industry December 2020

Final Level 1 Guidance
Docket Number:
FDA-2014-D-0622
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

FDA is issuing this guidance 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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0622.

 
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