2016 Will Be A Big Year For Combo Product Reform, FDA Says
This article was originally published in The Gray Sheet
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.
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The Senate HELP Committee voted March 9 in favor of a breakthrough device provision, watered down from a version approved in the House last year. Other bills voted out of committee include a combination products reform measure, the digital-health focused MEDTECH Act, and four others. Senators are still debating whether NIH and FDA should get additional funds to cover the cost of the bills, which will be wrapped up into a broader package before Senate floor debate.
Questions from companies and FDA reviewers about human factor design and data requirements for combination products continue to grow. In response, the agency has issued a draft guidance.
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