SHOULD ANTIBODIES BE REGULATED BY THE FDA ?

Jose Perdomo biotech at slip.net
Sat Apr 1 07:02:41 EST 1995


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.

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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