ISTOCK, LUISMMOLINAThe 21st Century Cures Act, approved by the US Congress and signed into law by former President Barack Obama last December, includes a provision to speed up the development and approval of cell- and tissue-based therapies, tissue engineering products such as scaffolds, and combination treatments. As of this month, four firms’ products have earned this so-called regenerative medicine advanced therapy (RMAT) designation.
“It really is very important. . . . You now have [a priority designation] that is very clearly for tissue and cell [therapies],” Beth Roxland, an associate at the NYU School of Medicine and a senior consultant on law, ethics, and policy, told The Scientist. “Overall, this piece of 21st Century Cures was very much a step in the right direction for prioritizing potentially life-saving therapies.”
The RMAT pathway (formerly called regenerative advanced therapy, or RAT) is analogous to the breakthrough designation designed for traditional drug candidates and medical devices. Specifically, it will allow companies developing regenerative medicine therapies to interact with the US Food and Drug Administration (FDA) earlier in the clinical testing process and more frequently, and RMAT-designated products may be eligible for ...
