FDA发布关于GDUFA下设施检查就绪状态与目标日期决定的最终指南

Facility Readiness: Goal Date Decisions Under GDUFA

AI 导读

FDA发布最终指南，说明其打算如何依据ANDA申请人通过Form FDA 356h所认证的设施检查就绪状态来设定目标日期。该指南对应GDUFA III承诺函（2023-2027财年）中FDA与行业商定的项目改进。文件编号为FDA-2022-D-1981，由CDER发布，公众可随时就该指南提交意见。

推荐理由

材料说明FDA将依据ANDA中Form FDA 356h所认证的设施检查就绪状态设定目标日期，可帮助申请人理解GDUFA III下的目标日期安排。

正文 · 原文

GUIDANCE DOCUMENT

Final

Docket Number:

FDA-2022-D-1981

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance provides information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter).

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-1981.