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GUIDANCE DOCUMENT

Best Practices in Developing Proprietary Names for Drugs May 2014

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

FDA is issuing this guidance to help sponsors of human drugs, including those that are biological products, develop proprietary names2 that do not cause or contribute to medication errors or otherwise contribute to the misbranding of the drug. This guidance describes design practices to help avoid such errors with proprietary names and provides a qualitative systematic framework for evaluating proposed proprietary names before submitting them for FDA review. This guidance does not address the selection of established names or proper names.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.