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

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