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From Our Perspective

FDA Approval Demonstrates the Role of Real-World Evidence in Regulatory Decision-Making on Drug Effectiveness

Ozlem Belen, MD, MPH, Deputy Director of the Division of Rheumatology and Transplant Medicine, Office of New Drugs

John Concato, MD, MPH, MS, Associate Director of Real-World Evidence Analytics, Office of Medical Policy

Stefanie Kraus, JD, MPH, Senior Regulatory Counsel, Office of Regulatory Policy

FDA recently approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection in adult and pediatric patients receiving lung transplantation. This action marked the first approval of an immunosuppressant drug to prevent lung transplant rejection. The approval is also significant because it reflects how a well-designed, non-interventional (observational) study relying on fit-for-purpose (i.e., reliable and relevant) real-world data (RWD), when compared to a suitable control, can be considered adequate and well-controlled under FDA regulations.

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