2016 Will Be A Big Year For Combo Product Reform, FDA Says
This article was originally published in The Pink Sheet Daily
Having earlier signaled its plan to propose a new statutory pathway for combination products by the end of 2016, the agency is now working on a bevy of process changes, guidance documents and rules to enhance premarket and postmarket regulation of combination products in the years ahead.
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FDA's concepts for new pathway could be ready for congressional scrutiny within a year.
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.
In an exclusive interview with "The Gray Sheet," FDA's Deputy Commissioner Robert Califf spoke about concerns the agency has with regulating combination products, provides tips for companies looking to get combo products to market and whether he'd consider taking on the role of FDA commissioner. Listen to our exclusive podcast or read the Q&A transcript.