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January 14, 2013News for the food and drug law community

  Drugs & Biologics 
  • EMA responds to France's scrutiny of combined contraceptives
    The European Medicines Agency supported the use of combined contraceptives after France raised questions about their safety. The agency said the "very rare risk of blood clots" was known. "There is currently no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today," the EMA said. Reuters (1/11) Email this Story
  • Telik's MDS candidate Telintra wins orphan-drug designation
    The FDA granted orphan-drug status to Telik's Telintra, or ezatiostat HCL, an experimental drug for myelodysplastic syndrome. In studies, Telintra was associated with multilineage response and the need for fewer red blood cell transfusions among MDS patients. RTT News (1/11) Email this Story
  • Indian panel reportedly will review compulsory cancer drug licensing
    The Indian government has created a panel to review issues tied to compulsory licensing and whether generic versions of three cancer drugs can be released, according to a source. Governments can let drugmakers produce patented medicines without consent from patent-holders under the World Trade Organization's compulsory licensing provision. The move could trigger new disputes in the area of intellectual property, experts said. The Economic Times (India) (1/14) Email this Story
  • Ky. activists voice concern over patent expiry of OxyContin
    Activists are worried that generics that lack the abuse-resistant protections of of Purdue Pharma's painkiller OxyContin will flood Kentucky after its patent expires in April. "You'll see a lot more oxycodone abuse again. You'll see a lot of overdoses. You'll see the ER visits. You'll see the funeral homes pick up business," activist and recovering addict Joshua Huffman said. United Press International (1/13) Email this Story
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Learn which employee incentives work best from research from Kellogg School of Management faculty. Learn more.
  Food & Dietary Supplements 
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Medical Devices 
  • Bayer's new IUD gains FDA approval
    Bayer HealthCare Pharmaceuticals received federal approval for its new intrauterine device, Skyla, to prevent pregnancy for up to 36 months. The device is designed to release 13.5 mg of levonorgestrel. Drug Store News (1/10) Email this Story
  • FDA OKs telepresence robot from InTouch Health
    InTouch Health has been cleared by the FDA to market the RP-VITA robot, which the company developed in collaboration with iRobot. The technology, which combines iRobot's mobility and autonomous navigation tool with InTouch Health's telemedicine system, is designed to provide doctors with remote access to acute care patients. (Boston) (1/10) Email this Story
  • Next-gen digital mammo platform from iCAD wins FDA nod
    The FDA has given iCAD approval for its PowerLook advanced mammography platform, which comes with capabilities for digital computer-aided detection. The approval allows the company to market the next-generation system with the microdose full-field digital mammography tool from Philips. (1/8) Email this Story
  Hot Topics 

Top five news stories selected by FDLI SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  FDLI Items 
  • Don't Miss FDLI Food Week 2013: Feb. 5-8 in Washington, D.C.
    FDLI's Food Week 2013 program is a unique opportunity for food law, regulation and policy stakeholders to hear first-hand from government officials and industry experts on the latest legal and regulatory developments. Food Week 2013 is a collection of four advanced one-day conferences, as well as FDLI's industry standard "Introduction to Food Law and Regulation" course. At this unique program, you set the menu -- attend one, two, three or all four conferences to make the most of your Food Week 2013 experience. Email this Story

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