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CBER's Regulatory Activity in 2018: A Reading List

 
• By Bridget Silverman

The US FDA's biologics center invested heavily in preparation for coming waves of advanced therapies. 

The US FDA's Center for Biologic Evaluation and Research spent much of 2018 laying the groundwork for a comprehensive regulatory framework for gene and cell therapy and other emerging areas of science. Below is a list Pink Sheet articles highlighting those efforts, which CBER undertook while it experienced a relatively quiet review year.

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