RMAT Designations: Lessons Learned on the “Clinical Evidence” Requirement
Published: | Updated:
The Regenerative Medicine Advanced Therapies (RMAT) designation was introduced by the 21st Century Cures Act as a pathway to accelerate FDA approval and market entry of regenerative medical therapies. Two years on, William Rose and Suchira Ghosh identify the trends in how FDA assesses the clinical evidence supporting successful RMAT candidates.