FDA 发布《使用非活性成分数据库》指南草案并征求意见（FDA-2019-D-2397）
Using the Inactive Ingredient Database
FDA 药品审评与研究中心发布指南草案，介绍其非活性成分数据库（IID）并给出在药品研发中使用该数据库的建议，文件编号 FDA-2019-D-2397，属非约束性建议且不可用于实施。指南还说明 IID 的结构、辅料数据以及命名、最大效力水平和计量单位的呈现方式，并称其可用于评估辅料安全性，这会影响申报受理与科学审评。公众可通过在线或书面方式随时提交意见，书面意见须标注该案卷编号。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-2397
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance describes the Food and Drug Administration’s (FDA’s) Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products. The guidance also describes how the IID can be used in evaluating excipient safety, which can affect application filing and scientific review. In addition, this guidance discusses how the IID is structured; the data regarding excipients in the IID; and how nomenclature, maximum potency levels, and units of measure are presented in the IID. Lastly, the guidance is intended to give IID users a clearer understanding of the database’s benefits and limitations.
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-2019-D-2397.
来源：FDA Pharmaceutical Quality Documents · fda.gov