The main areas of focus in this guidance are as you probably guessed from its title, the issues of minimal manipulation and homologous use. The FDA also issued a second finalized guidance entitled “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.” It includes a hand-dandy flow chart for figuring out how to apply all the complicated criteria. This 27-pager has a lot to take in, but I’ll try to summarize my initial impressions even as I’m hoping to do a deeper read in coming days. Given the apparent conflict between the industry reality of all those non-compliant clinics at the moment and the words in the finalized guidance, many of us are very curious as to what happens next. is a drug manufacturing process generally requiring FDA approval, which most of these clinics do not have. The take home from this in my view is that production of what is often called “fat stem cells” (or stromal vascular fraction) as is done by hundreds of for-profit clinics in the U.S. Why? Because they wouldn’t qualify as what the FDA calls “such HCT/P” since they are by definition more than minimally manipulated. 15(b): Questions and Answers Regarding the Scope of the Exception”) is the clarification that fat stem cells are not going to be exempt from oversight as a drug even in the context of a same surgical procedure. There’s a ton to read through in all these guidances, but on my initial run through, practically speaking one of the most important stem cell policy elements of this particular finalized guidance (entitled “Same Surgical Procedure Exception under. The first of today’s newly released, finalized guidances relates to the so-called “same surgical procedure exception” and clarifies when an exemption is likely to be in effect and when it isn’t. This follows on some action and a bold statement a few months earlier from Gottlieb and his agency. Scott Gottlieb also issued a statement today again highlighting the importance of differentiating between good citizens in this arena and as he puts it “bad actors”. In this post I’m mainly going to focus on the two finalized guidances and then the two draft guidances will be covered in more depth in a later post. Overall, the FDA’s goal is to establish a clear and “modern” framework, as they put it, for oversight of the regenerative medicine arena including related to the 21st Century Cures Act provisions. Are today’s developments a good thing overall? I’d say “yes”, although there are still some ambiguities and a more accurate answer might be “Yes, but it’s complicated.” Fat stem cells are drugs There will be a 90-day comment period for the latter. 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 draft form. Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question.
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