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CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System

 
• By Derrick Gingery

Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.

Patient triage tent
CBER wants to triage cell and gene therapy submissions after sponsors raised concerns about timeliness. • Source: Alamy

Cell and gene therapy sponsors could see some submissions gain attention at the US Food and Drug Administration sooner that those already on file if they are deemed more important to the development program.

Center for Biologics Evaluation and Research Director Peter Marks said staff are working on a triage process for some submissions,...

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