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US FDA’s Biologics Center Faces Exciting 2019 After Quiet Year For Novel Approvals

 
• By Bridget Silverman

CBER’s novel biologic approvals in 2018 were few, long, and with a low level of innovation. But the center’s work to build regulatory framework for emerging technologies is setting the stage for a different story in 2019.

Pink Sheet prespectives 2018 to 2019

The US FDA’s Center for Biologics Evaluation and Research had a slow 2018 by many regulatory metrics. CBER’s novel approval tally was one of the smallest in recent years, with a marked increase in average time to approval and few products qualifying for expedited review programs.

But the center was also quite actively laying the groundwork for new regulatory frameworks for regenerative medicine and new efforts to work with sponsors and other FDA offices – efforts

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