Best practices in developing proprietary names for human prescription drug products

Best practices in developing proprietary names for human prescription drug products

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Labeling
Medication Errors -- prevention & control
Prescription Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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. This guidance applies to all human prescription drug products. In this guidance, all such products are jointly referred to as products, and persons responsible for developing the products are referred to as sponsors. FDA is separately developing guidance on best practices in developing proprietary names for nonprescription drug products.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (various pagings)).
NLM Unique ID:
9918249609906676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918249609906676