Industry Praises Combo Product Rule But Still Seeks New Postmarket System

The Combination Products Coalition, a coalition of combination product manufacturers, praises FDA's newly released final rule on combination products for addressing industry concerns about the scope and clarity of the rule. The 2009 proposed rule was widely criticized for being confusing and creating duplicative reporting requirements, and FDA's final version clarifies the rule's scope, streamlines reporting requirements, extends certain compliance deadlines and promises guidance to aid with compliance. But FDA declined to take the advice of multiple industry groups, including...