Category Archives: Op-Ed

Trending: Wearables and Invisibles

I can’t help imagining the cocktail party of 2018 as a scene from one of those a low-budget sci-fi film aired late at night. Imagine: A living room packed with people too busy to chat with each other as they balance their drinks with one hand and monitor their sleeves of devices and smartphones with […]
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Breakthrough Therapy Program Exceeds FDA’s Expectations

The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner,  according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years, for several critical […]
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CMS Struggles to Fix Sunshine System

The feds have “a long way to go” to get the Open Payments system operating effectively and user friendly, according to officials in charge of the financial disclosure program. “Sunshine” went live September 30, 2014, as scheduled, but incomplete and contradictory data listings made it necessary to withhold nearly one-third of financial transaction reports from […]
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New Republican Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.  Voters were most dismayed about the economy and lack of jobs, but U.S. military snafus overseas and concerns about the Ebola […]
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We Need to Rock the Boat to Make Research Soar

By Wayne Kubick, Applied Clinical Trials. We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive—or even survive. Controlled clinical trials take too long and cost too much. Regulatory review is blocking innovation. Research data must be shared transparently, drug manufacturers need to […]
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