News from the healthcare data industry
Docket Number:FDA-2022-D-2983 Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence This guidance provides recommendations to sponsors and investigators considering the...
Aetion and FDA will use the Aetion Evidence Platform® to study crucial oncology research questions to advance the mission of the Oncology Center of Excellence’s Scientific Collaborative NEW YORK, Jan. 24, 2023 /PRNewswire/...
SAN FRANCISCO, Jan. 18, 2023 (GLOBE NEWSWIRE) — Datavant, the leader in enabling organizations to securely connect health data, has achieved a major information security designation, Federal Risk and Authorization...
Foundation Medicine’s liquid biopsy test can now be used by oncologists to identify more patients with rare mutations within their cancer for whom treatment with Rozlytrek may be appropriate January...
Federally supported project will advance solutions on race and ethnicity data for research (December 15, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) is launching the Real-world Accelerator to Improve...
Partnership leverages Aetion’s platform for analyzing real-world data to generate evidence and support regulatory decision-making NEW YORK, Dec. 7, 2022 /PRNewswire/ — Aetion, the global leader in real-world evidence (RWE) technology and analytics,...
FDA’s draft guidances on real-world data do not provide strict requirements for industry stakeholders to abide by, but they offer patient advocacy organizations with a clearer understanding of how to...
CADTH, the Canadian health technology appraisal (HTA) body, is consulting on draft guidance on the use of real-world evidence in submissions to both regulatory and HTA decision makers. The aim...
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...
November 25, 2022 The EU has awarded 7 MEUR to HUS Helsinki University Hospital led Consortium, which aims to unlock the full potential of real-world data collected in European cancer...