SHOULD ANTIBODIES BE REGULATED BY THE FDA ?
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
Please, post your comments on this issue.
Thanks in advance.
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