RWE Alliance – Healthcare Data News

June 21, 2024July 5, 2024 Competitor News Government/Regulatory

Stakeholders request elaboration, consistency in FDA’s non-interventional RWE studies guidance

Reacting to new regulatory draft guidance on observational studies, stakeholders asked the US Food and Drug Administration (FDA) to flesh out its advice with examples and to ensure consistency with...

November 29, 2022December 2, 2022 Government/Regulatory Industry News

Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices

It is striking how collaborative the real-world evidence (RWE) ecosystem is: a distributed community with multiple nodes of authority working toward a coherent, transparent approach to real-world data and evidence...

March 9, 2022March 11, 2022 Competitor News Government/Regulatory

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

March 09, 2022 04:15 PM Eastern Standard Time WASHINGTON–(BUSINESS WIRE)–Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration’s (FDA) recent draft...

January 24, 2022January 25, 2022 Government/Regulatory Industry News

RWE Alliance Submits Comments on FDA’s RWE Draft Guidance, Highlights Recommendations for Agency’s RWE Program and RWE Derived from EHR/Claims Data

January 24, 2022 04:12 PM Eastern Standard Time WASHINGTON–(BUSINESS WIRE)–Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration (FDA) draft guidance on using...