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FDA approval for treatment

Richard Schifreen rschifre at access4.digex.net
Sun Jul 16 13:05:28 EST 1995


Any treatment offered for sale in the United States must get FDA 
approval.  I can't speak to the regulations in Canada.  Not all products 
need to be completely defined, but they will certainly ask how you insure 
that each and every lot is safe and effective.

Rich Schifreen

On 16 Jul 1995, Lim Pohyam wrote:

> From the discussions generated from Jay's PCR note, I wonder if a treatment 
> regime for alcoholics should get FDA approval to be sold in the US or 
> Canada? We have been approach to try FDA approval for a Chinese herbal cure 
> for alcoholism. My main concern is that some herbal components may not be 
> defined in specific terms. Could anyone tell me?
> 
> 
> 



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