There has been great concern raised about a Statement the FDA Commissioner issued on November 16, 2017, due to the forceful comments he made about non-compliant physicians and clinics offering a variety of “unproven” therapies for use in treating a large number of pathologies. But what motivated the Commissioner to issue the letter last November?...
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Physicians using FDA-compliant therapies (BMC and PRP are the only ones currently) are frustrated by having to compete with over-the-line, lunch-sponsoring, media-savvy, modern day snake oil sales organizations who say whatever it will take to charge patients for receiving miracle cures. Some physicians wonder why it takes the FDA so long to deal with these...
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Last year a really biased post was written by Dr. Paul Knoepfler, (UC, Davis) on the secrets he claims stem cell clinics have told him over the years. Needless to say, these so-called secrets portray “stem cell clinics” as engaging in outright fraudulent activity as they purport to provide therapeutic treatments. My main beef with...
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Greyledge Hemoanalytic Data
In the last two posts (When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One andWhen Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part Two), I reviewed a situation involving a 510(k)-cleared device/kit for mechanically disrupting a patient’s adipose tissue (i.e.,...
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Amniotic Fluid-derived Information
In the previous post When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One, I introduced what I think is a curious situation that has resulted from instructions the FDA provided to physicians on how to review the standards outlined in 1271.15(b) to see if they can invoke the...
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Lipogems Adipose Tissue
During my previous review(see posts): When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part Two of important and relevant points the FDA made in the two Guidances that were issued on...
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In the previous post: When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One, I started reviewing relevant statements that I think might apply to adipose tissue in the two final Guidances the FDA issued on November 16, 2017 (see my views and the link below): Winners and...
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Safe Medical Environment
Prior to the FDA issuing the final versions of two Guidances (see my views and links below) Winners and Losers Emerge at Long Last After the FDA Issues Two Guidances  Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part Two...
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In the previous post: Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One, I started exploring what I think the FDA is trying to tell us stakeholders in its recently issued Guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception”. I...
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