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Senate Bill Aims At Streamlining Combination Product Regulation

This article was originally published in The Tan Sheet

Executive Summary

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.


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