US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals

 
• By Sarah Karlin-Smith
  
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CBER’s Nicole Verdun said the FDA is using the principles of the platform approach in situations that don’t qualify for the agency’s new incentive.

FDA's Office of Therapeutic Products Director Nicole Verdun
CBER Office of Therapeutics Director Nicole Verdun spoke on a 14 May Cencora webinar. • Source: Cencora ThinkLive Cell and Gene Therapy Summit

The US Food and Drug Administration is applying the principles of the platform technology designation to situations that may not technically qualify for the program in order to speed the approval of multiple indications for cell and gene therapies.

Key Takeaways

  • Sponsors may be able to take advantage of the platform technology designation concept without a qualifying product.

The platform technology pathway was created by the 2022 Food and Drug Omnibus Reform Act to streamline development of products...

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