Expediting Drug Development: FDA's New Regenerative Medicine Advanced Therapy Designation

A Vaggelas, D Seimetz - Therapeutic Innovation & Regulatory Science 2019, Vol. 53(3) 364-373

…In March 2017, the US FDA introduced the new Regenerative Medicine Advanced Therapy (RMAT) designation thus recognizing the enormous potential of these medicines and the need for efficient regulatory tools to accelerate their development and their commercial …

Current state of US Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon

M Mendicino, Y Fan, D Griffin, KC Gunter, K Nichols - Cytotherapy, 2019, Vol. 21(7) 699-724

… vital new legislation affecting the CGT field, such as the Regenerative Medicine Advanced Therapy (RMAT) designation…