SHOULD ANTIBODIES BE REGULATED BY THE FDA ?

rcolling at olivet.edu rcolling at olivet.edu
Thu Apr 6 23:10:35 EST 1995


In article <3ljfd1$3e4 at slip-1.slip.net> Jose Perdomo <biotech at slip.net> writes:
>From: Jose Perdomo <biotech at slip.net>
>Subject: SHOULD ANTIBODIES BE REGULATED BY THE FDA ?
>Date: 1 Apr 1995 12:02:41 GMT

>The FDA has recently expanded their regulatory reach to classify an 
>extensive group of antibodies as Medical Devices Class II. The most
>likely result of the implementation of such regulatory overreach 
>is that, due to the high cost of these submisions, these antibodies 
>will become unavailable in USA.  This will hamper Immunology research,
>cancer research, reduce the quality of health care in US, all in 
>exchange for bureocratic gains that are guarantee to cost tax payer 
>money and improve nothing.


This would be a regulatory nightmare and strongly influence immunology 
research in a negative manner.
IMHO
Rick Colling











>Should we allow FDA to restrict the scientific freedom by 
excessive>regulatory policies.

>Please, post your comments on this issue.

>Thanks in advance.

>Jop





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