FDA approval for treatment

Jack H. Pincus jhpincus at cris.com
Sun Jul 16 18:44:03 EST 1995

In article <199507161432.WAA24999 at einstein.technet.sg>, 
pohyam at TECHNET.SG says...
>From the discussions generated from Jay's PCR note, I wonder if a 
>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 
>for alcoholism. My main concern is that some herbal components may not 
>defined in specific terms. Could anyone tell me?

Getting the FDA to approve a herbal cure would be difficult because the 
herbal mixture is undefined.  You would have to know the which are the 
active ingredients.  In addition, approval will be more difficult to 
obtain if more than one ingredient is involved.

Pharmaceutical and biotechnology companies are very interested in 
traditional medicine.  However, the raw materials are only starting 
points.  They pursue the active ingredient, purify it, and use it for 
clinical trials.

Jack H. Pincus
jhpincus at cris.com

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