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Senate Bill Aimed At Streamlining Combo Product Regulation

This article was originally published in The Gray Sheet

Executive Summary

A Senate bill would streamline device/drug combination registrations at FDA by letting the agency 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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