Cell Therapies: US FDA Asked To Clarify Development Standards For Early-Phase Trials

 
• By Sue Sutter

Academic institutions confused about agency standards are overly cautious in requiring early-phase studies be conducted under full GMPs, experts say; CBER Director Marks highlights regulatory flexibility but cautions that formal written guidance could be misused by those in stem cell industry.

3d illustration of immune system T cells attacking cancer cells (CAR T-cell therapy) - Illustration
The US FDA is being urged to clarify early clincial development standards for CAR-T. • Source: Shutterstock

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