Tag

Blood-derived preparations
Cord Blood-Derived HCT PS

Cord Blood-derived HCT/Ps Remain ‘351 Category Products – Part Two

In the last post, I covered the rapidly expanding sales of donor cord blood-derived products, despite the fact that the FDA considers cord blood to be a biological drug, and requires companies to perform an IND to gain approval to sell cord blood units. In the previous post, I focused on a company, Invitrx, which...
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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.,...
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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...
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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...
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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...
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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...
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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...
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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...
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Winners and Losers Emerge at Long Last After the FDA Issues Two Guidances

In my last post,  I continued my discussion about Dr. Paul Knoepfler’s “out there” heavily biased blog post on the alleged evils of stem cell clinic’s patient treatments with “…non-FDA approved offerings.” Today, I am going to discuss the importance of two recently issued FDA Guidances. For some of us, November 16, 2017 will be...
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