21st Century Cures Act stem cells

Fat stem cells are drugs & more: FDA final guidances point to a new era

FDA-stem-cell-policy-flow-chart-e1510854295902

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in …

Fat stem cells are drugs & more: FDA final guidances point to a new era Read More »

How Scott Gottlieb may transform the FDA’s approach to stem cells

Dr.-Scott-Gottlieb

The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to  the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such …

How Scott Gottlieb may transform the FDA’s approach to stem cells Read More »

Good stem cell news on trials, FDA, cool new papers & more

Pericyte-paper

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive. The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile …

Good stem cell news on trials, FDA, cool new papers & more Read More »

FDA Regenerative Advanced Therapy Designation Rules Are Up in Response to Cures Act

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 …

FDA Regenerative Advanced Therapy Designation Rules Are Up in Response to Cures Act Read More »

Perspectives on Cures Act stem cell provisions possible benefits & risks

EnergyCommerceLogo_ORANGE-e1480522761962

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 …

Perspectives on Cures Act stem cell provisions possible benefits & risks Read More »

Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions

Michael-Werner-Pic

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 …

Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions Read More »