Posted by Michael Wonder on 05 Aug 2021
From Our Perspective: FDA approval demonstrates the role of real world evidence in regulatory decision-making on drug effectiveness
4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection in adult and paediatric 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.
