There is considerable interest in FDA regulatory reform here in the U.S. for stem cell therapies. The goal is to get new treatments to patients faster, but is there a way to do that without sacrificing proven safety and efficacy? You need convincing data on both safety and efficacy or speed becomes dangerous. A group called the Bipartisan Policy Center (BPC) recently issued a report related to these central questions of American regulation of new stem cell products. You can see a screenshot from the cover …Read More
With growing pressure, including political pressure on the FDA, to deregulate the point-of-care, for profit stem cell clinic industry, one can only imagine a future in which deregulation has taken its natural course…..that’s what I’ve done in the political cartoon above. A “double shot” takes on a whole new meaning.