Celltex has issued a press release (PR), entitled “Company Pioneering Regenerative Medicine Services Invited FDA to Inspect Lab” on their FDA audit in response to the reaction in the media and stem cell community about it. I view this PR as a step in the right direction–more openness! There is a lot of info in …
The Texas State Medical Board reportedly approved new rules for the use of adult stem cells. The ruling was at least in part a result of Texas Governor and former GOP presidential hopeful, Rick Perry, strongly pushing the issue. Perry himself received a controversial, non-FDA approved stem cell transplant in 2011 as part of a …
Are stem cells a drug? Should the FDA regulate them? Technically, the FDA calls stem cells “biologics”, but the FDA regulates stem cell products with the goal of ensuring safety and efficacy much the same as traditionally define chemical “drugs”. You can learn more about the FDA’s view of and concerns about stem cells here and here. …