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Senate Bill Aimed At Streamlining Combo Product Regulation

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.

The Combination Product Regulatory Fairness Act of 2015 is intended to improve “an outdated and inefficient regulatory process” for innovative drug and device combination products, according to Sen. Johnny Isakson, R-Ga.

Isakson cosponsored the bill with Sens. Robert Casey, D-Pa., and Pat Roberts, R-Kansas. S

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