FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Details Submission Requirements for New Regenerative Advanced Therapy Designation

Jan. 27, 2017

The FDA has introduced a new designation for regenerative medicine therapies, laying out the submission requirements for sponsors seeking expedited review that stems from the 21st Century Cures Act.

The regenerative advanced therapy (RAT) designation applies to cell therapies, therapeutic tissue engineering products, human cell and tissue products, or any combination of these, intended to treat a life-threatening condition.

A request for the designation should be submitted either concurrently with an investigational new drug application (IND) or as an amendment to an existing application, the agency said.

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