Gene Therapy And Accelerated Approval: US FDA Mulls Pooling Data To Shrink Postmarket Studies

 
• By Sarah Karlin-Smith

The head of CBER's Office of Therapeutic Products also touted hiring achievements and new communication plans with sponsors at an Alliance for Regenerative Medicine meeting. 

swimming pool with lots of people sitting on side dangling legs in
The FDA wants to make gene therapy postmarket studies more feasible, such as by pooling data from multiple indications. • Source: Shutterstock

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