FDA发布产品质量评估获益-风险考量指南草案（编号FDA-2022-D-0168）

Benefit-Risk Considerations for Product Quality Assessments

AI 导读

FDA发布《产品质量评估获益-风险考量》指南草案，说明其在评估产品质量相关的CMC信息时应用的获益-风险原则。草案适用于依据FD&C法案505条提交的新药申请、依据PHS法案351条提交的生物制品许可申请及其补充申请，评估时还会参考检查发现等其他信息。文件注明为草案、不用于实施且建议不具约束力，案卷编号为FDA-2022-D-0168，可随时在网上或邮寄提交意见。

推荐理由

该草案说明FDA审评CMC信息时如何纳入获益-风险考量，并列出以案卷号提交意见的渠道，可帮助读者定位其适用范围。

正文 · 原文

GUIDANCE DOCUMENT

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2022-D-0168

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA assessment as part of original new drug applications (NDAs) under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), original biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act), or supplements to such applications, in addition to other information (e.g., inspectional findings) available to FDA during its assessment.

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-2022-D-0168.