To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 90 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 248 requests and issued 101, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 41% of RMAT applications get approved (101 approvals / 248 applications = 40.7%). [Read more…]