FDA’s Broad-Based Effort to “Modernize” Combination Product Regulatory Process in Full Swing

FDA’s broad-based effort to “modernize” its regulatory process for products that contain some combination of drugs, biologics and devices gained significant momentum during 2016, and the impact of the effort will continue to increase as 2017 progresses.

Better assessing and addressing the challenges involved in coordinating the diverse regulatory requirements, processes, timelines, and philosophies that are in play with combination products has become a top FDA priority. The agency’s goal is to establish a more supportive regulatory environment for industry innovation in this rapidly evolving arena.

Among the significant steps that have been taken by FDA over the past year to drive governance, process and outreach improvements is the creation of the cross-cutting Combination Products Policy Council – the first such policy council that is agency-wide.

Set up in April 2016, the council brings agency leaders together to provide the strategic oversight needed to break down silos and ensure a coherent, risk-based approach to the regulation of this diverse set of products.

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