By Edward Stopke 23 Jan 2017
Meddevicetracker Weekly News Write-Up, January 23, 2017.
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By Anju Ghangurde 23 Jan 2017
The Trump presidency and the threat of protectionism, new generic opportunities beyond the US market, and the need for new quality benchmarks were some of the key issues discussed at the recent annual day celebrations of the Indian Drug Manufacturers’ Association.
By derrick-gingery 19 Jan 2017
Incoming president not holding over any FDA political appointees from the Obama administration, but what exactly his stamp on the agency will be remains unclear.
By Bowman Cox 17 Jan 2017
Congressional oversight agency urges FDA to make better use of foreign offices with more effective performance measures and staffing goals; GAO notes agency’s progress towards risk-based inspections – and its plan to revisit every site at least once every five years.
By Amanda Maxwell 17 Jan 2017
2017 is going to be a pivotal year for EU medtech regulations. We are expecting the new Medical Devices Regulation and IVD Regulation to take effect. But there are some big concerns and uncertainties at the center of it all.
13 Jan 2017
Highlights from Biomedtracker’s daily reports from the J.P. Morgan Healthcare Conference include products advancing in NASH, competition in CAR-T and more.
By Jessica Merrill 12 Jan 2017
Daily round-up of news and notes from the 2017 J.P. Morgan Healthcare conference in San Francisco. Regeneron CEO rebuffs Amgen’s patent battle strategy; Teva CEO apologizes for reduced financial guidance; Merck looks for more Keytruda wins, combos; Lilly awaits potentially differentiating Phase III CDK4/6 data; Alkermes readies ALKS 5461 depression submission; Biden discusses cancer moonshot; FDA’s real world evidence views; and UniQure turns a corner
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