Earning RMAT Designation - What Developers Need To Know

To get new therapies to market and help severely ill patients faster, the U.S. Food and Drug Administration (FDA) offers a series of expedited programs, each of which is intended to accelerate complex regulatory processes for specific therapies. These programs – such as the Regenerative Medicine Advanced Therapy (RMAT) designation – are crucial to help bring cell and gene therapies to patients that have life-threatening diseases with unmet medical needs.

However, developers of regenerative medicines often face complex clinical trials and evolving regulatory hurdles which increase risk of failure. Explore a high-level overview about the RMAT designation and how you can ensure success and advance your product toward commercialization.