Combo Product Safety: US FDA Rule On Post-Market Reporting Nears Finalization
Industry is eagerly awaiting guidance on combination products, and after seven years the adverse-event reporting regulation may be at top of the agency’s queue.
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FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.
Bradley Thompson has been shepherding the Combination Products Coalition for more than a decade. He says the recent spotlight from FDA and other policymakers put on the combo-products space, including in a recent user-fee deal, is a welcome development after a period of neglect. Thompson spoke to Medtech Insight about the numerous reforms in the works and the state of the sector.
The agency released an internal assessment of how it handles intercenter consultations for combination products. As expected, there are some serious challenges to collaboration between the centers, but FDA says it is taking tangible steps to make it better.