The FDA is giving a gentle but clear nudge to industry on stem cells with a new rapid-response program to help regenerative medicine makers to get on the right side of the law.
The Tissue Reference Group’s Rapid Inquiry Program (TRIP) promises to answer sponsors’ questions about what regulations govern their products within three days of receiving them. It’ll run through the end of the year. The program will serve as an “informal” adviser to sponsors and treatment makers, where they can find out how their products should be classified and the various paths to approval.
The FDA laid out a comprehensive regulatory framework for stem cells and other modern therapies in November 2017 but promised to give sponsors and makers 36 months of “enforcement discretion” to come into compliance.
“However, we’re more than halfway through the enforcement discretion period, and the pace of progress… has been slower than expected,” Acting FDA Commissioner Ned Sharpless said.