Re: [DIYbio] Re: Fwd: Stem cells are drugs according to FDA

On Fri, Feb 3, 2012 at 1:10 AM, CodonAUG <elsbernd@gmail.com> wrote:
> Stem cells are biologics and do not fall under the same category as
> small molecule drugs.  Similar issues apply to the way antibodies are
> produced and used as drugs.  If this kind of wording/loophole is not
> used (and it has to because congress wont change the FDA) then you
> will have a bunch of clinics popping up that use stem cells that are
> not tested for safety and efficacy before being sold.
>

Are you saying that FDA regulates biologics? (what's the loophole
you're referring to?)


--
Nathan McCorkle
Rochester Institute of Technology
College of Science, Biotechnology/Bioinformatics

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