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Regulating Cell Therapies: Conditional Approval Under Consideration In Congress; FDA Plans Public Hearing

Does FDA need a new pathway to consider advances in cellular therapy? Some in Congress think so. FDA is inviting stakeholders to weigh in this fall.

A conditional approval pathway for cell therapies is likely to receive legislative attention in the next round of user fee reauthorization in 2017.

The proposal has been introduced in the form of the REGROW Act (S. 2689

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