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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

Calls for the US Food and Drug Administration to clarify its flexibility on cell therapy development standards must be balanced against concerns about how such formalized leniency could be interpreted among purveyors of stem cell therapies, an agency official said.

At a meeting on the future of cell therapies, industry representatives and researchers urged the agency to clarify its view...

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