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June 20, 2020
Foundation Medicine struck a huge blow for the advancement of biomarker-driven cancer treatments last week.   The Cambridge, MA-based company won approval from FDA for FoundationOne CDx to work as a... Read more
June 20, 2020
Even as he coronavirus disease 2019 has reached global pandemic levels, the time is right to encourage community oncology practices to expand their offerings by enabling clinical trial enrollment for... Read more
June 19, 2020
FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.  The accelerator is organized by the Reagan... Read more
June 19, 2020
Real-world evidence covers clinical insights on potential benefits or risks of a medical product taken from real-world data — information derived from registries, electronic health records, claims... Read more
June 18, 2020
Washington, DC – Today, the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, announce the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder,... Read more
June 18, 2020
A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of... Read more
June 18, 2020
The FDA has joined a public-private diagnostic research project with the goal of bringing more real-world data to bear against the novel coronavirus, and gauging the accuracy of different kinds of... Read more
June 11, 2020
Executive Summary Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps.... Read more
June 10, 2020
The remote monitors and telehealth check-ins made necessary by the coronavirus could become permanent fixtures of new clinical trials going forward, FDA Commissioner Stephen Hahn said.   The pandemic... Read more
June 2, 2020
Executive Summary The coronavirus pandemic could be a turning point for master protocol and platform trial designs, but clear guidance and coordination are still needed. Two former US Food and Drug... Read more

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