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GUIDANCE DOCUMENT

CVM GFI #240 Proprietary Names for New Animal Drugs June 2020

Final
Docket Number:
FDA-2018-D-0626
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Under section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) a drug is misbranded if its labeling (including labels) is false or misleading in any particular. A drug product’s labeling can be misleading because of the representations it makes, or because it omits material facts about possible consequences of using of the drug as intended.

The Code of Federal Regulations (CFR) describes some of the ways that the proprietary name of a drug can make its labeling misleading. See 21 CFR 201.6(b) and 21 CFR 201.10(c).

This guidance provides recommendations to help new animal drug sponsors (you) develop proprietary names that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This guidance provides a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). It also explains how you can request that CVM evaluate a proposed proprietary name. This guidance does not address the established names of animal drugs. This guidance does not apply to heritable intentional genomic alterations in animals.


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-2018-D-0626.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002
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