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RMAT Designations: Lessons Learned on the “Clinical Evidence” Requirement
November 2, 2018
Suchira Ghosh
Pharmaceutical Executive

Axinn counsel Suchira Ghosh co-authored an article entitled, “RMAT Designations: Lessons Learned on the 'Clinical Evidence' Requirement" for Pharmaceutical Executive. The article discusses the 21st Century Cures Act and how the FDA designates Regenerative Medicine Advanced Therapies (RMAT) in accordance with the Cures Act. The article also examines the correlation between the rarity of conditions and the process by which the FDA designates their compatible RMATs, as well as the future for RMAT designation.

Click here to access the article.