FDA 发布 Q3D(R2) 元素杂质指南草案并开放征求意见（案卷号 FDA-2013-D-1156）
Q3D(R2) Elemental Impurities
FDA 网站列出 Q3D(R2) 元素杂质指南，文件标注为 2022 年 9 月发布的草案，案卷号为 FDA-2013-D-1156。该指南由 FDA 药品评价与研究中心（CDER）发布，页面说明可随时提交线上或书面意见。书面意见须注明该案卷号，也可邮寄至 Dockets Management 的 Rockville 地址。
材料给出 Q3D(R2) 元素杂质指南的文件状态、案卷编号与征求意见方式，可用于核对文件信息与提交渠道。
GUIDANCE DOCUMENT
Q3D(R2) – Guideline for Elemental Impurities International Council for Harmonisation; Draft Guidance for Industry September 2022
Final Level 1 Guidance
- Docket Number:
- FDA-2013-D-1156
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
International Council for Harmonisation; Draft Guidance for Industry
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-2013-D-1156.
来源：FDA Pharmaceutical Quality Documents · fda.gov