To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 102 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 279 requests and issued 128, 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 46% of RMAT applications get approved (128 approvals / 279 applications = 45.9%). [Read more…]