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Adult Stem Cell News and Developments other than Cytori
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TOPIC: Regulatory Developments at the FDA

Regulatory Developments at the FDA 03 Nov 2015 07:33 #5391

  • fas
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We all know- dealing with the FDA takes time and to be honest I do not have the time to stay on top of that. Its ages ago that the guidance from the FDA came out and Cytori commented on them and seemed pleased with them. However- the industry status- i.e. the wild wild west of ADRC clinics- has not changed at all.

Luckily Alexey Bersenev does that on his two pages in respect of the regenerative industry developments.

Recently the FDA came out with a new guidance on "homologous use" one of these important terms in respect of regulation.

File Attachment:

File Name: 2015-FDAHomologousUseGuidance.pdf
File Size: 120 KB

Alexey writes on that...

FDA just released a new draft guidance document, which explains homologous use of therapeutic cell and tissue products (HCT/P) in details. The reason for such clarification was “many inquiries from manufacturers about whether their HCT/Ps meet the homologous use criterion”. I agree, determination of homologous/ non-homologous for some HCT/P applications could be confusing. Unfortunately, in my opinion, this guidance does not clarifies all confusing cases – yes, I’m talking about adipose tissue, stromal vascular fraction (SVF) and mesenchymal stromal cells (MSC).

more you can read in his article : HERE

In his Cells Weekly summary, he comments on the market reaction of the paper:

This week FDA released new document, where definition of homologous use cell/ tissue product is clarified. Investors of at leas two companies – MiMedx and Osiris Therapeutics reacted to this news by dropping a stock share price >10%.
Both MiMedx and Osiris have a history of frictions with FDA on their marketing of 361 tissue products. FDA is planning to have a public hearing next year on 4 recent HCT/P guidance drafts, including: minimal manipulation, same surgical procedure, homologous use and adipose tissue.

So from what he writes, we can expect some final resolvement on the regulatory side of SVF in 2016.... :KO:

About time :evil:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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