Infographic: Milestones in the FDA’s Real-World Evidence activities

The passing of the 21st Century Cures Act of 2016 marked a sea change within the FDA, spurring the agency to develop a number of initiatives advancing the role and use of real-world evidence (RWE) and data (RWD) across the spectrum of health care and regulatory decision-making. This infographic, created by The Evidence Base®, charts the history of the FDA's RWE activities since 2016 and is intended to help our readers navigate the landscape of the various FDA resources and guidelines. The infographic was updated in March 2024 following publication of the new draft guidance 'Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.' Click on the icons within the infographic below to go directly to the resources at the FDA. If you'd like to receive a PDF copy of this infographic, or are interested in sponsoring future infographics across areas of RWE, health economics and outcomes research and market access, please email Phil Garner. [pdf-embedder url="https://www.evidencebaseonline.com/wp-content/uploads/2023/07/FDA-RWE-Infographic-Update-March-2024.pdf" title="FDA RWE Infographic Update March 2024"] Source: Real-World Evidence You may also be interested in: How the FDA are using real-world evidence in regulatory decision-making: an interview with Nicholaas Honig, Aetion PDUFA VII and the FDA Advancing Real-World Evidence Program: an interview with Lucy Vereshchagina, PhRMA Jeff Trotter: Tell me about your experiences in interacting with clients and FDA in early discussions to support approvals