Category

News

The FDA Commissioner Brings the Hammer Down on Rogue Clinicians Offering “Unproven” Regenerative Medical Therapies

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?...
Read More

An Oldie But a Goodie: RTI Surgical is Awarded a Warning Letter

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...
Read More

Creating a Storm Without Enlightening Anyone: Paul Knoepfler Shares His Frustrations with Stem Cell Clinics Part Three

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...
Read More
Greyledge Hemoanalytic Data

Practical Implications for Physicians Wanting to Use the Lipogems System for Processing Lipoaspirate Part One

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.,...
Read More
Amniotic Fluid-derived Information

When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part Two

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...
Read More
Lipogems Adipose Tissue

When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One

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...
Read More

When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part Two

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...
Read More
Safe Medical Environment

When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One

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...
Read More

Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part Two

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...
Read More

Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One

The FDA issued two Guidances on November 16, 2017; one on homologous use and minimal manipulation, and the other on the Same Surgical Procedure Exception in 21 CFR 1271.15. See, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception” for the text of the Guidance. Also, see...
Read More
1 2 3 6