On January 9, 2015, the Department of Justice announced that Daiichi Sankyo, a Japanese corporation who has its United States headquarters in New Jersey, was fined $39 million as a result of violating the False Claims Act by paying kickbacks to physicians to induce them to prescribe drugs manufactured by […]
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When did Olympus first learn about the design problems inherent in the specialized medical scopes it peddles? Did they have plans to redesign these scopes to make them safer for patients? These are the questions at the top of U.S. Representative Ted Lieu’s (D-CA) mind after he sent a letter […]
A reported 100,000 Americans, including a 54-year-old Illinois man and 36-year-old North Carolina woman, have reported severe side effects from Levaquin, an antibiotic that packs enough pill power to kill anthrax. Levaquin, a drug classified in the fluoroquinolone family, is now undergoing another Food and Drug Administration evaluation because of the controversy. Twelve […]
New Medications Meet Unmet Patient Needs The Food and Drug Administration’s approval of 41 novel new drugs in 2014 made it a banner year for the pharmaceutical industry. The class of 2014 included biologicals, drugs that treat cancer and infectious diseases (bacterial, fungal, parasitic and viral) and therapeutic drugs. The […]
At the Food and Drug Administration’s Center for Devices and Radiological Health, the new year started off with an approval of the first therapeutic weight loss option for obese patients since 2007. The device – the Maestro Rechargeable System – was given a thumbs-up following a scientific study of a […]
Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities. The other two goals focus on 1) striking a better balance between data collection requirements and the time […]