FDA 发布《人用处方药专有名称开发最佳实践》指南草案（FDA-2020-D-0770）
Best Practices in Developing Proprietary Names for Human Prescription Drug Products
FDA 发布指南草案 FDA-2020-D-0770，针对人用处方药专有名称开发提出最佳实践，旨在减少名称相关用药错误，并避免采用可能导致违反 FD&C 法案及其法规的专有名称。该草案属 Level 1 指南，不具约束力，不可用于实施，由 CBER 与 CDER 发布，未涉及既定名称或通用名称的指定。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2020-D-0770
- 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 nonprescription drug products develop proprietary names2 16 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 available to sponsors to use for nonprescription drug products before a product bearing that proprietary name is marketed. 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-2020-D-0770.
来源：FDA Pharmaceutical Quality Documents · fda.gov