January 2017 – Drug and Device Digest

RAT (Regenerative Advanced Therapy Designation) & OTAT (Office of Tissues and Advanced Therapies)


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)


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