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September 17, 2018
FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new... Read more
September 14, 2018
A potential resolution to a lingering debate on how the government should oversee laboratory-developed diagnostic tests would focus the FDA’s attention on the more cutting-edge and riskier screening... Read more
September 14, 2018
The American Society of Clinical Oncology proposed four ways to lower financial barriers that impede cancer patients' ability to participate in clinical trials, including a recommendation to improve... Read more
September 13, 2018
As Congress crafts new legislation on diagnostics to update a system first built in 1976, the US Food and Drug Administration (FDA) has offered feedback that will help to shape a modern framework... Read more
September 11, 2018
A negative coverage recommendation proposed by the Oregon Health Authority could restrict access to next-generation sequencing tumor profiling for some of the most vulnerable residents in the state,... Read more
August 30, 2018
Executive Summary Recent draft guidance documents address adolescent enrollment in adult cancer trials, use of cohort designs in early-phase studies, and inclusion of placebo controls; more advice is... Read more
August 22, 2018
Executive Summary One of the hallmarks of the “breakthrough” era has been the rapid expansion of first-in-human trials into pivotal studies for efficacy submissions. In a new draft guidance, FDA... Read more
August 21, 2018
Executive Summary The American Clinical Laboratory Association (ACLA) split with other stakeholder groups in criticizing US FDA’s proposals for a new diagnostics regulatory regime. ACLA asked... Read more
August 14, 2018
Executive Summary Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.   Death,... Read more
August 10, 2018
In a Friends of Cancer Research (Friends) meeting devoted to real-world evidence, members of the cancer community generally agreed that its use has an increasingly important role to play in gathering... Read more