Posted by Michael Wonder on 20 May 2026
FDA official offers examples of RWE being used to secure drug approval
19 May 2026 - An official from the US FDA on Monday presented three case studies demonstrating how sponsors effectively utilised real world evidence and real world data to secure approval for their products.
Motiur Rahman, a senior epidemiologist and policy advisor in the Office of Medical Policy at the Center for Drug Evaluation and Research, spoke at the Regulatory Education for Industry meeting on 19 May. Rahman discussed common characteristics of applications that have incorporated real world evidence and real world data and have gone on to receive approval.
