Innovation Drives Divergence: US FDA Drugs and Biologics Centers Follow Own Trajectories

Regenerative medicines using expedited review pathways dominate novel approvals at the Center for Biologics Evaluation and Research, while the Center for Drug Evaluation’s higher volume comes with lower first-cycle approval rates and more standard reviews.

Pink Sheet Perspectives
The US FDA's drugs and biologics centers increasingly follow different regulatory routes as the agency accommodates the growing regenerative medicine pipeline. (Shutterstock)

The long-building wave of cell and gene therapies has transformed the profile of novel approvals at the US Food and Drug Administration’s Center for Biologics Evaluation and Research, placing it on a growth trajectory increasingly divergent from the larger Center for Drug Evaluation and Research.

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