Here are five things to know.
1. The RMAT, which stems from a provision in the 21st Century Cares Act, is a new expedited approval program for drugmakers seeking approval for innovative regenerative medicines like cell therapies, therapeutic tissue engineering products, and human cell and tissue products.
2. To earn the new designation, the drug must provide a previously unmet clinical need for a serious or life-threatening disease.
3. Drugmakers can submit a request for the designation with or after submitting an investigational new drug application to the FDA.
4. Drug companies that obtain the RMAT designation for a product are eligible to receive increased or earlier interactions with the FDA — similar benefits to drugs given a breakthrough therapy designation. The drugmakers may also earn a priority review status or accelerated approval of the drug.
5. “We have started receiving RMAT designation requests and expect that, as with Breakthrough Therapy Designation, early and frequent communication facilitated by the RMAT designation will help reduce overall product development times,” said Peter Marks, MD, PhD, in a blog post on the FDA’s website.
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