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