Posted by Michael Wonder on 23 May 2017
New FDA pathway to accelerate development of cell therapies
22 May 2017 - Four products have already qualified for the regenerative medicine advanced therapy designation that provides extra interactions with the agency, and sooner.
The 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 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 and a senior consultant on law, ethics, and policy at the NYU Langone Medical School, told The Scientist. “Overall, this piece of 21st Century Cures was very much a step in the right direction for prioritising potentially life-saving therapies.”
