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Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?

 
• By Derrick Gingery

CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.

gene therapy
• Source: Shutterstock

A regulatory turf war could emerge in the coming years as gene therapy development advances and more emphasis is placed on the manufacturing process, said Peter Marks, who heads the US Food and Drug Administration center now in charge of the products.

In the next 10 to 20 years, Marks, director of the Center for Biologics Evaluation and Research, suggested he and Center for Devices and Radiological Health Director Jeffrey Shuren may...

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