Senate Bill Aims At Streamlining Combination Product Regulation
This article was originally published in The Tan Sheet
A Senate bill would streamline device/drug combination registrations by letting FDA rely on prior PMAs and approved drug findings to help support new product approvals, among other reforms. It was introduced by Sen. Johnny Isakson, R-Ga., and co-sponsored by Sens. Robert Casey, D-Pa., and Pat Roberts, R-Kansas.