Archive for June 13th, 2016

Will the FDA’s New Combination Products Policy Council Help with Key Decision-Making for Combination Products?

In March, the FDA spearheaded a lean management model that will transform the combination product review process. Now, the federal agency has introduced a new committee that will address industry policy issues, a change that could have a significant effect on manufacturers. The Combination Products Policy Council will centralize the classification and review process, which, the FDA claims, will “ensure alignment and consistency” across the board. But will the reforms really help with combination product decision-making? Read more »