FDA 发布质量相关受控函件问答最终指南（FDA-2017-D-6821）

Questions and Answers on Quality Related Controlled Correspondence

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FDA 发布质量相关受控函件问答最终指南，阐述其对这类提交中常出现的质量科学与监管问题的当前看法。文件编号 FDA-2017-D-6821，为最终版 Level 2 指南，由 CDER 发布。FDA 说明该指南仅作建议，除非被纳入合同，否则不具有法律效力。

推荐理由

该最终指南汇总 FDA 对质量相关受控函件中常见科学与监管问题的当前看法，可帮助读者定位其在这类提交上的既有立场。

正文 · 原文

GUIDANCE DOCUMENT

Final Level 2 Guidance

Docket Number:

FDA-2017-D-6821

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This questions and answers (Q&A) guidance provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in controlled correspondence submissions. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.

This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

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-2017-D-6821.