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In the News

July 2, 2020
Executive Summary Duke-Margolis' Mark McClellan touts the advantages networks have over individual operations, citing the dexamethasone RECOVERY trial, and notes need for real-world evidence... Read more
July 1, 2020
Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there... Read more
June 30, 2020
Covid-19 vaccine tests should include racial and ethnic minorities, pregnant women, and patients with underlying health conditions, the FDA said, echoing calls from patient advocates to broaden the... Read more
June 26, 2020
Real-world data is everywhere. During the COVID-19 global pandemic, we are literally generating, and collecting, real-world data every single day—from electronic health records, insurance claims,... Read more
June 25, 2020
The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel,... Read more
June 23, 2020
The ongoing coronavirus disease 2019 (COVID-19) pandemic has magnified the value of real-world data (RWD) in oncology. The FDA is presently spearheading several initiatives aimed at refining the role... Read more
June 23, 2020
Janet Woodcock, one of the FDA’s most powerful regulators, has an almost mythic reputation and an outsized personality to match. For years, rumors have swirled: Who could possibly succeed her?   Now... Read more
June 22, 2020
The US Food and Drug Administration (FDA) is collaborating with the Reagan-Udall Foundation and Friends of Cancer Research for a project called Covid-19 Diagnostics Evidence Accelerator.   The... Read more
June 22, 2020
To take an additional step toward harnessing real-world data to help inform the agency’s overall response to the covid-19 public health emergency, FDA has announced its participation in the Covid-19... Read more
June 22, 2020
The US Food and Drug Administration's recent tissue-agnostic approval of pembrolizumab (Merck's Keytruda) using tumor mutational burden as a predictive biomarker has sparked debate among oncologists... Read more

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