What will FDA’s new rules mean for legitimate stem cell treatments?

When the Food and Drug Administration last week issued guidelines for investigative stem cell therapies, much of the attention fell to the agency’s vow to crack down further on unregulated clinics offering potentially unsafe treatments.

But the guidances also have plenty of ramifications for companies trying to bring to market innovative and legitimate stem cell treatments by moving them through clinical trials and getting them approved by the FDA.

Following up on the regenerative medicine portions of last year’s 21st Century Cures Act, the FDA detailed how it will grant priority review and accelerated approval statuses to stem cell therapies and how it will determine what qualifies as a “regenerative medicine advanced therapy,” or RMAT, which would allow for a more streamlined regulatory process. (Some of the guidances remain in draft form and are open to comment for the next few months.)

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