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 submissions, these antibodies
will become unavailable in USA. This will hamper Virology research,
cancer research, reduce the quality of health care in US, all in
exchange for bureaucratic 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.
JP.
