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shivas38

11/13/14 12:29 PM

#81851 RE: HAE12 #81849

If they cited the company in guidance they will.
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karlm34

11/13/14 1:11 PM

#81856 RE: HAE12 #81849

Remember, the Oct 2014 Draft guidance pertains to the collection and processing of the cells and guidelines to prevent the introduction, transmission, and spread of communicable diseases in the cells. It does not give authority to any company to use the cells to treat, cure or prevent disease.

Still need FDA approval to use the cells to treat, cure or prevent disease. Read the last paragraph. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm

It does however, help their CMC section of their INDs.