The Role of RWE in FDA Regulatory Decisions
March 29, 2021
RWE (real world evidence) and RWD (real world data) have risen in prominence when it comes to clinical trial design and utilizing existing patient records to draw conclusions. The 2016 21st Century Cures Act has led to the FDA placer greater importance and value on RWE in the context of its regulatory decisions. A new review discusses challenges in the use of RWE as well as the intrinsic benefits associated with RWE.
“Real-world evidence (RWE) has garnered increased attention in recent years to advance drug development. The framework for the Food and Drug Administration’s (FDA’s) RWE Program, published in 2018, serves as a roadmap for the inclusion of real-world data (RWD) and RWE in regulatory decisions, including standards on how RWD are defined, collected, and analyzed. This article reviews the use of RWE in United States (US) regulatory decisions after the publication of the FDA’s RWE framework and describes how manufacturers can leverage RWE to optimize their product launch.” Read more here.
(Source: Aishani Patel, PharmD & Trent McLaughlin, BSc(Pharm), PhD, AmerisourceBergen Xcenda, 2/25/21)