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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
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
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Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say.The...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
August 14, 2019
The clinical development of treatments for breast cancer that has metastasized to the brain often stalls because of the hurdle presented by the blood–brain barrier, but preclinical literature... Read more
August 14, 2019
San Francisco-based data company Syapse said Wednesday that it has signed a multi-year research collaboration agreement with the US Food and Drug Administration’s (FDA) Oncology Center of Excellence... Read more
August 13, 2019
There may be no single cure, but there are nearly as many cancer treatments as there are types of the disease. Since 1975, the five-year survival rate for all cancers has risen by 36 percent. Yet... Read more