FDA 发布《研究数据技术一致性指南》技术规格文件（FDA-2014-D-0092）

Study Data Technical Conformance Guide - Technical Specifications Document

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美国 FDA 发布《研究数据技术一致性指南》技术规格文件，文件编号 FDA-2014-D-0092，属最终版指南，由药品评价与研究中心（CDER）发布。该文件反映 FDA 当前在该主题上的思路，不赋予任何人权利，也不约束 FDA 或公众，可采用满足相关法规要求的替代方法。公众可随时就该指南提交意见，书面意见须注明文件编号 FDA-2014-D-0092。

正文

GUIDANCE DOCUMENT

Final

Docket Number:

FDA-2014-D-0092

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, send an email to [email protected] or [email protected].

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-2014-D-0092.