By: Matthew Fischer
The regenerative medicine arena consists of a wide range of innovative products. Congress, acknowledging the importance of this field, has established a new program via the 21st Century Cures Act to help spur development and provide for accelerated approval for regenerative medicine products similar to the FDA’s fast track and breakthrough therapy designations. This new approval is the Regenerative Medicine Advanced Therapy (RMAT) Designation.
The RMAT Designation includes all the benefits of the FDA’s other accelerated designations including early agency engagement and priority review; however, unlike the other designations, the RMAT Designation does not require evidence that the product offers substantial improvement over other therapies. For a drug to be eligible for the RMAT Designation, it must meet the following:Continue reading