Monday, March 12, 2012
The biotech industry and FDA
agree that pending accelerated approval legislation would facilitate expansion
of the pathway to conditions beyond HIV/AIDS and cancer, but they have different
opinions about the pace and scope of change that should be expected.
BIO, which hammered out the accelerated approval
proposals in discussions with FDA, expects a quick spike in the percentage of
drugs marketed under accelerated approval and a boost in funding for emerging
companies as investors are persuaded that expansion of accelerated approval
will reduce regulatory risk.