FDA Pharmaceutical Quality Documents·· 2012-12-06AI 评分57
FDA发布最终指南限制特定邻苯二甲酸酯在CDER监管产品中作为辅料使用
Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products
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FDA发布行业最终指南，限制特定邻苯二甲酸酯作为辅料用于CDER监管产品。该文件档案编号为 FDA-2012-D-1135，标注为2012年12月的最终指南，由CDER发布。FDA表示可随时就该指南在线或书面提交意见，书面意见需注明上述档案编号。
正文
GUIDANCE DOCUMENT
Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products Guidance for Industry December 2012
Final
- Docket Number:
- FDA-2012-D-1135
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
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-1135.
来源：FDA Pharmaceutical Quality Documents · fda.gov