FDA Aims To Establish Predictable Premarket Path For Combo Products

In keeping with the goals of the 21st Century Cures Act, FDA on Tuesday (Feb. 5) published draft guidance aimed at laying out predictable premarket review pathways for combination products. In its guidance, the agency states a single premarket application can be used for a combination product -- as is laid out in Cures -- and explains how applicants can determine which type of premarket submission is appropriate based on the product’s leading component. A lead agency review center will...