FDA采用富集策略的临床试验支持药物和生物制品的审批

2019-09-04 美国食品和药品监督管理局 FDA

Docket Number:

中文标题：

英文标题：

Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products Guidance for Industry

发布机构：

美国食品和药品监督管理局

发布日期：

2019-09-04

简要介绍：

Docket Number:: FDA-2012-D-1145
Issued by:: 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 “Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.” The purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate effectiveness (and in some cases safety) of human drugs and biological products. This guidance defines several types of enrichment strategies, provides examples of potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. This guidance finalizes the draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” issued on December 17, 2012.

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