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Platform Technology Designation A Gene Therapy Opportunity, OTP Director Verdun Says

 
• By Derrick Gingery

The new designation could streamline development of multiple products that use the same backbone, said Nicole Verdun, director of the US FDA’s Office of Therapeutic Products.

train platform
The new platform technology designation program eventually could help multiple sponsors developing gene therapies with the same backbone. • Source: Shutterstock

Office of Therapeutic Products Director Nicole Verdun sees the new platform technology designation as another pathway to expedited approval of gene therapies from the same sponsor and eventually, multiple sponsors.

The 2022 Food and Drug Omnibus Reform Act, which renewed several US Food and Drug Administration user fee programs, created the designation, which could allow expedited review of multiple products that use a similar technology

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