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Podcast: FDA's Califf Talks About Combo Product Reform, Commish Prospects

This article was originally published in The Gray Sheet

Executive Summary

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.

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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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