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2016 Will Be A Big Year For Combo Product Reform, FDA Says

The agency has already signaled its plan to propose a new statutory pathway for combination products by the end of next year. In the meantime, it's working on a bevy of process changes, guidance documents and rules to enhance premarket and postmarket regulation of combination products in the years ahead. Office of Combination Products officials John Weiner and Thinh Nguyen weigh in.

Questions about the future regulation of combination products came to a head in 2015, and it's likely that significant changes will be put on the table in 2016.

From FDA, companies can expect a comprehensive proposal for a new approval pathway focused on combination products by the end of next year that could dovetail with efforts to reauthorize...

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