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September 5, 2019
It has been six months since Scott Gottlieb announced that he would be resigning as commissioner of the US Food & Drug Administration, and there is still no formal nominee to succeed him.   That... Read more
September 4, 2019
Just a few days after a report surfaced noting that HHS Secretary Alex Azar was pushing for controversial secretary for health Brett Giroir to take the helm at the FDA from acting chief Norman “Ned”... Read more
September 4, 2019
The jockeying over who will be the next Food and Drug Administration commissioner intensified Tuesday when former agency heads and dozens of health groups urged the White House to nominate acting FDA... Read more
September 4, 2019
Ned Sharpless, acting commissioner of the U.S. Food and Drug Administration, has won the support of five previous agency chiefs — Republican and Democratic appointees — and nearly 60 healthcare... Read more
September 4, 2019
Five former FDA commissioners and dozens of patient groups have publicly asked President Donald Trump and HHS Secretary Alex Azar to nominate acting FDA Commissioner Ned Sharpless as permanent... Read more
August 26, 2019
Dive Brief: After holding a series of meetings with stakeholders and adding Sen. Richard Burr, R-N.C., as a new lead sponsor, Congress is working toward releasing an updated Leading-edge IVCT... Read more
August 25, 2019
One of the hot topics at this year’s ASCO Annual Meeting was broadening eligibility criteria to increase clinical trial access and enrollment.   Eligibility criteria are intended to ensure patient... Read more
August 15, 2019
Executive Summary Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine. The US Food and Drug Administration will work with Syapse... Read more
August 14, 2019
Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say.The... Read more
August 14, 2019
A Conversation With Chief Medical Officer Andrew Norden, MD, MPH, MBA When it comes to generating evidence that leads to a drug approval, the randomized controlled trial (RCT) is the gold standard.... Read more