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Off Topic on Adult (=regenerative) cell technology, but very much related i.e. pills and drugs of which we do not know if they work
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TOPIC: FDA Draft Guidance

FDA Draft Guidance 17 Nov 2014 05:11 #2691

  • fas
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  • May the fat be with you
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We informed the board a while ago on the "new guidance" by the FDA on the cell based therapy regulations codified in 21 CFR 1271.15(b).

back in 2006 CBER i.e. the FDA made the mistake in specifically mentioning PRP (Platelet Rich Plasma) as allowed use by doctors in the US. Most of the protocols for PRP are a whole lot more "manipulation" than extracting cells from fat tissue be it manually or by Celution.

The FDA is planning to correct their "mistake" by defining exactly what "minimal manipulation" is, which apparently EXCLUDES centrifugation.

This process is simply needed to separate waste from cells in all procedures, meaning PRP and BM fresh cells will fall under FDA "Biologics" control.

If you disagree with that - Centeno and the Adult SC advocates organized a vehicle to voice one´s displeasure.

Your urgent help is needed!

Mind you- personally I am totally on Centeno´s and the patients side- but also am clear to the fact that the law favors "law abiding" Companies like Cytori.
The following user(s) said Thank You: d9dozrman, keysman

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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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