Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early Phase Clinical Trial; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry." The draft guidance document provides recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early phase clinical trial for a single disease. Sponsors have expressed interest in gathering preliminary evidence of safety and activity using multiple versions of a cellular or gene therapy product in a single clinical trial, where each version is a distinct product that should be submitted to FDA in a separate investigational new drug application (IND). The draft guidance describes the regulatory framework for conducting such studies, including recommendations on how to organize and structure the INDs, submit new information, and report adverse events.