About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The report findings were derived from focus group studies with reviewers from the FDA’s different centers and included input from industry. Since then, we have built on foundational policies and processes to address many of the issues identified in the report.

Tremendous progress toward modernizing the combination products review program has been made by improving coordination, ensuring consistency, enhancing clarity, and providing transparency within the agency as well as with all stakeholders. We are excited to share our progress with you now. The table below summarizes some key achievements from the past year, including the publication of draft guidances, a variety of new processes, and a look at future goals.

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