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From:
U.S. Food and Drug Administration
(Uncensored)
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Regenerative Medicine Advanced Therapy Designation | FDA
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation
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Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.