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Requiring FDA Guidances Does Not Always Advance The Science, Gene Therapy Director Says

 
• By Derrick Gingery

OTAT Director Wilson Bryan says important cell and gene therapy guidances came from clear community needs, not user fee program requirements.

Cell therapy
The FDA's infusion of user fee capital for cell and gene therapy work likely will take years to create an impact. • Source: Shutterstock

A guidance mandate in the new US Food and Drug Administration user fee program may feel like a win, but it will only help industry if the agency is ready to opine on the subject, a senior official said.

The FDA must write several new guidances, including some related to cell and gene therapies, as part of the prescription...

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