Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability

Food and Drug Administration: 12/17/2012

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). This document defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. Read more