In a conversation hosted by the Friends of Cancer Research and the American Society of Clinical Oncology, cancer researchers spoke with regulators and industry to lay out ways to modernize cancer…
Washington, DC - April 12, 2021 - Friends of Cancer Research would like to congratulate Dr. Patrizia Cavazzoni for being named the director of the Center for Drug Evaluation and Research (CDER) at…
Though cancer clinical trials have taken a hard knock from COVID-19, preserving and extending pandemic flexibility may give oncology research broader reach than ever before, according to Janet…
FDA acting chief aims to use Covid-19 fight to advantage
Electronic records can replace burdensome paper forms
Physicians running clinical trials may have less paperwork in the future by relying…
Executive Summary
In an interview with Medtech Insight, Amy Abernethy, the US FDA’s outgoing second-in-command, threw her weight behind Janet Woodcock to be the agency’s next commissioner. News of…
To the Editor—A recent federal notice1 proposes to permanently remove oversight by the US Food and Drug Administration (FDA) over 91 medical devices, including several devices that apply artificial…
Real-world evidence, post-marketing studies, and migrating clinical trial sites into underserved communities are all strategies the U.S. Food and Drug Administration (FDA) is pushing to help increase…
Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out? While patient advocates and the research community have been strong advocates…
Executive Summary
After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop…
Executive Summary
US FDA principal deputy commissioner Amy Abernethy is set to leave the agency by the end of April. The surprise news comes in the midst of the Biden administration still figuring…