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How Can FDA Advance Cell Therapy R&D? Issue Guidance in ‘Real Time,’ Encourage Collaboration With Industry, CBER’s Marks Says

 
• By Kate Rawson

CBER will take a page out of the drug center’s book and start issuing shorter guidances more quickly; sponsors should also be on the lookout for an RIF on ways to collaborate with agency.

real time concept
• Source: Shutterstock

The Center for Biologics Evaluation & Research wants to publish guidance documents in “real time” and find ways to work more collaboratively with sponsors on fast-moving areas of drug development like cell therapies, while still being able to “hold ourselves accountable” as regulators, CBER Director Peter Marks said.

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