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Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks

 
• By Sue Sutter

Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.

Off-ramp
Accelerated approval sometimes has been 'like an off-ramp for problems' with an application, FDA's Peter Marks said. • Source: Shutterstock

When it comes to making efficient use of the US Food and Drug Administration’s expedited regulatory pathways, more planning and work needs to happen earlier in the process rather than being an afterthought, Center for Biologics Evaluation and Research director Peter Marks believes.

Speaking at the American Society of Gene and Cell Therapy annual meeting on 17 May, Marks said the current accelerated...

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