Latest News & Insights

RWE Alliance Lauds FDA for Reaching Major Milestone in RWE Program

Washington, D.C. (October 15, 2024) – The RWE Alliance issued the following statement applauding the U.S. Food and Drug Administration (FDA) for reaching a major milestone in its RWE Program by recently finalizing guidance required by the 21st Century Cures Act: “The RWE Alliance is pleased that the Agency has now finalized the core suite […]

Washington, D.C.,

RWE Alliance Applauds FDA for Publishing RWE Submissions Data, Encourages FDA To Continue To Enhance Communication and Transparency Around the Use of RWE in Regulatory Decision Making

Washington, D.C. (August 20, 2024) – The RWE Alliance issued the following statement in response to the U.S. Food and Drug Administration’s report on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) that contain real-world evidence (RWE): “The RWE Alliance commends the Agency for recently […]

Washington, D.C.,

Five Leading Real-World Data and Analytics Organizations Join the RWE Alliance, Doubling Membership

Washington, D.C. (April 5, 2022) – The RWE Alliance is pleased to announce the addition of five new members—ConcertAI, OM1, Syneos Health, Verana Health, and Verily—to continue to advance policies to support regulatory use of real-world evidence (RWE). The RWE Alliance is a policy and advocacy coalition of real-world data (RWD) and analytics organizations with a […]

Washington, D.C.,

RWE Alliance Submits Comments on All Four Recent FDA RWE Guidances, Looks Toward Further Engagement to Advance Use of RWE to Benefit Patients

Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration (FDA) draft guidance on using electronic health records (EHRs) and medical claims data to support regulatory decision making across therapeutic areas.

Washington, D.C.,

RWE Alliance Submits Comments on FDA’s RWE Draft Guidance, Highlights Recommendations for Agency’s RWE Program and RWE Derived from EHR/Claims Data

Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration (FDA) draft guidance on using electronic health records (EHRs) and medical claims data to support regulatory decision making across therapeutic areas.

Washington, D.C.,

RWE Alliance Supports Califf Nomination, Urges Continued Focus at FDA on Advancing Use of Real-World Evidence to Benefit Patients

The RWE Alliance supports the nomination of Dr. Robert Califf to serve as Commissioner of the U.S. Food and Drug Administration (FDA).

Washington, D.C.,

Leading Real-World Data and Analytics Organizations Form Industry Coalition to Advance Policies to Support Regulatory Use of Real-World Evidence

RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus

Washington, D.C.,