RMAT Designations: Lessons Learned on the “Clinical Evidence” Requirement

The 21st Century Cures Act (Cures Act), signed into law in December 2016, was designed to reduce regulatory obstacles for FDA approval of innovative medical therapies and accelerate the process of bringing innovative products to patients in need. Included in the Cures Act was a pathway to accelerate FDA approval and market entry of regenerative medical therapies, such as cell therapies or human tissue products, known as the Regenerative Medicine Advanced Therapies (“RMAT”) designation.