FDA发布人用注射剂多剂量、单剂量和单人用容器包装类型术语与标签建议最终指南
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
FDA宣布发布最终指南，针对人用注射剂在多剂量、单剂量和单人用容器中包装时，就包装类型术语和丢弃声明的选择提出建议。该指南将2015年10月22日发布的草案定稿，文件编号为FDA-2015-D-3438。FDA表示可随时对任何指南提交意见，书面意见需注明该文件编号，邮寄至其文件管理部门。
该最终指南由2015年10月22日草案定稿，涉及多剂量、单剂量和单人用容器注射剂的包装类型术语与丢弃声明建议。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2015-D-3438
- Issued by:
-
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.” This guidance finalizes the draft guidance issued October 22, 2015, which provides recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers.
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-2015-D-3438.
来源：FDA Pharmaceutical Quality Documents · fda.gov