October 24, 2020

The Niche

Knoepfler lab stem cell blog

21st Century Cures Act stem cells

1 min read

The 21st Century Cures Act specifies some new FDA rules about investigational stem cell-based regenerative medicine therapies and perhaps most importantly defined a new class of product called a “Regenerative Advanced Therapy” or RAT, which is entitled to an expedited review. The FDA already has a new page up on RATs, which specifies the specifics of RAT designation and how an entity may submit an application for RAT designation. This was remarkably fast of the FDA. Some things on the RATs page stand out including …Read More

4 min read

The 21st Century Cures Act has some important provisions that would impact the stem cell and regenerative medicine field.  What is driving these efforts is a widespread sense that the status quo of regenerative medicine oversight isn’t working very well. I’m talking with key stakeholders and still trying to sort out my thoughts on the stem cell provisions in Cures. What would it mean? Cures’ language on stem cells is nuanced and its provisions also are not so black and white as REGROW was in …Read More

3 min read

One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much discussion today. The bill is called Cures for short and you can read the latest draft here. Cures may get a vote in Congress as early as tomorrow so this is …Read More