FDA 发布 ANDA 原料药和制剂稳定性测试最终指南
ANDAs: Stability Testing of Drug Substances and Products
FDA 发布最终指南，建议依据《联邦食品、药品和化妆品法案》505(j) 条提交的 ANDA 及支持 ANDA 的 DMF 遵循 ICH 稳定性指南中的稳定性建议。文件编号为 FDA-2012-D-0938，由 CDER 指南发布办公室发布。页面说明可随时在线或书面提交意见，书面意见需标注该文件编号。
该最终指南建议 ANDA 及支持其的 DMF 参照 ICH 稳定性指南，可用于了解 ANDA 稳定性资料与 ICH 指南的衔接。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2012-D-0938
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance recommends that abbreviated new drug applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act, and the drug master files (DMFs) that support ANDAs, follow the stability recommendations provided in the International Conference on Harmonisation (ICH) stability guidances.
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-2012-D-0938.
来源：FDA Pharmaceutical Quality Documents · fda.gov