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In the News

July 24, 2020
NEW YORK – Friends of Cancer Research will soon release a tumor mutational burden calibration tool that developers of next-generation sequencing assays can use to correct the variability in how TMB... Read more
July 24, 2020
Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies. A surge in applications to test and develop new... Read more
July 23, 2020
Although PDUFA VI still has two years of life left to it, PDUFA VII is already in the birthing process, with the use of real-world data (RWD), AI, and a coming surge of novel cell and gene therapies... Read more
July 21, 2020
The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed... Read more
July 21, 2020
In the first six months of 2020, amid a pandemic, the US Food and Drug Administration approved 21 precision oncology drugs, blowing past the number of approvals during the same period last year and... Read more
July 16, 2020
Harmonizing measurement and reporting of biomarkers in oncology represents a cross-disciplinary challenge that also cuts across industry, regulatory bodies, academic, and clinical practice. As cancer... Read more
July 15, 2020
The House Energy & Commerce Committee on Wednesday (July 15) passed five bipartisan FDA policy bills that would increase the agency’s authority over imported counterfeit medical devices, stop... Read more
July 15, 2020
The FDA announced a new research project to collect real-world data from insurance companies and electronic health records on the use of diagnostic tests and medications for COVID-19. The agency is... Read more
July 13, 2020
A White House effort to undermine Anthony S. Fauci has drawn rebukes from public health experts, scientists and mostly Democratic politicians, who argue it is dangerous for the Trump administration... Read more
July 10, 2020
As the 21st Century Cures Act approaches its 4th anniversary, the National Comprehensive Cancer Network® (NCCN®) convened a working group made up of multidisciplinary experts from across the country... Read more