FDA 发布评估待批申请中药品生产场地的替代工具最终指南

GUIDANCE DOCUMENT

Final Level 1 Guidance

Docket Number:

FDA-2023-D-3031

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Alternative Tools:  Assessing Drug Manufacturing Facilities Identified in Pending Applications.” This guidance provides information to applicants on how FDA intends to use alternative tools to assess drug manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027” (PDUFA VII commitment letter) and “Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027” (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic. This guidance finalizes the draft guidance of the same title issued on September 22, 2023.

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-2023-D-3031.