RAT.JPG

WHAT: Resource for seeking designation as Regenerative Advanced Therapy – RAT

  • Cell therapy, therapeutic tissue engineering product, human cell and tissue product, any combination

WHY: Described in Section 3033 of the 21st Century Cures Act

WHEN: Either concurrently with IND submission or as an IND amendment

WHO: CBER, Office of Tissues and Advanced Therapies (OTAT)

LEARN

Published by Drug & Device Advisory Group


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