FDA 发布《现场警示报告提交：问答》最终指南，编号 FDA-2018-D-2326

Field Alert Report Submission: Questions and Answers

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FDA 发布最终指南《现场警示报告提交：问答》，就 NDA 和 ANDA 申请人提交现场警示报告（FAR）的要求说明其当前思路，并给出提交建议。文件由检查与调查办公室、CDER 和 CBER 发布，同时回应若干常见问题，编号为 FDA-2018-D-2326。公众可在任何时间通过线上或书面方式就该指南提交意见。

推荐理由

文件列出 NDA 与 ANDA 申请人提交现场警示报告的要求与建议，并汇总常见问题，便于核对报送口径。

正文 · 原文

GUIDANCE DOCUMENT

Final Level 1 Guidance

Docket Number:

FDA-2018-D-2326

Issued by:

Guidance Issuing Office

Office of Inspections and Investigations

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions.

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-2018-D-2326.