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In the News

January 8, 2019
Executive Summary Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.   Sponsors may desire... Read more
January 3, 2019
Executive Summary Siding with coalition of hospitals, judge ruled that HHS lacked authority to cut Medicare reimbursement for drugs purchased at 340B prices. That should change the dynamics of the... Read more
January 2, 2019
Executive Summary Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach... Read more
December 17, 2018
The US Food and Drug Administration (FDA) announced Monday that Dr. Amy Abernethy will replace Rachel Sherman as Principal Deputy commissioner of Food and Drugs – the highest position at the agency... Read more
December 17, 2018
Friends of Cancer Research Applauds this Appointment and Thanks Dr. Rachel Sherman for Her Incredible Service   December 17, 2018 - Washington, DC - Today, the U.S. Food and Drug Administration (FDA... Read more
December 17, 2018
One of the leading voices in using health data to advance targeted treatments known as precision medicine has been tapped for the second-highest post at the FDA.   Amy Abernethy, chief medical... Read more
December 17, 2018
Executive Summary Abernethy comes to FDA from Flatiron Health, which develops oncology-specific electronic health record software and real-world evidence for cancer research. She succeeds FDA veteran... Read more
December 17, 2018
Executive Summary O’Brien assumes role from his late colleague and friend Dan Best as HHS closes out administrative items in the blueprint.   The Trump Administration appears to be ramping up towards... Read more
December 13, 2018
Executive Summary Record-setting pace of NME approvals is a cause for celebration. But is it a sign that drug industry R&D productivity has actually improved? The US FDA’s top drug review... Read more
December 11, 2018
Federal regulators put two experimental drugs targeting autism’s core symptoms on a fast track for testing and approval this year, but they’re still a long way from pharmacy shelves.   Balovaptan,... Read more