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For Cell And Gene Therapies, Expedited Designation And Complex Questions Improve FDA Meeting Chances

 
• By Sue Sutter

Designation as a regenerative medicine advanced therapy or breakthrough therapy ‘dramatically increases’ the likelihood of getting a meeting with the agency, Office of Tissues and Advanced Therapies’ Wilson Bryan says; more complex and innovative products, and more challenging questions, also are likely to win sponsors an audience with the FDA.

Complicated wires
The more complicated the product, the more likely a cell or gene therapy sponsor is to have its meeting request granted by the FDA. • Source: Shutterstock

Developers of cell and gene therapies are more likely to have their meeting requests granted by the US Food and Drug Administration if their product has expedited pathway designation or if the questions at issue are particularly complex, Office of Tissues and Advanced Therapies director Wilson Bryan told the recent annual meeting of the American Society of Gene and Cell Therapy.

If a product is designated under the FDA’s regenerative medicine advanced therapy or breakthrough therapy programs, this “dramatically increases” the...

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