FDA introduces regenerative advanced therapy designation

FDA posted eligibility requirements for regenerative advanced therapy (RAT) designation, a new expedited review designation created by the 21st Century Cures Act (see BioCentury, Dec. 5, 2016).

Eligible regenerative therapies are defined as cell therapies, therapeutic tissue engineering products, human cell and tissue products. Some combination products are also eligible. Products eligible for the designation must treat a "serious or life-threatening" disease or condition, and preliminary clinical evidence must show that it may address an unmet need...