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January 29, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA warns of liver injury risk from tolvaptan
    Otsuka America Pharmaceutical's kidney drug Samsca, or tolvaptan, may cause irreversible and potentially deadly liver injury, and providers should promptly conduct liver tests on patients reporting symptoms, according to the FDA. Otsuka informed the FDA that three trial participants who took tolvaptan developed liver problems, and their conditions improved after they stopped taking the drug. Medscape (free registration) (1/25) Email this Story
  • EMA to consider blood clot risks of newer contraceptives
    The European Medicines Agency will review third- and fourth-generation combined oral contraceptives' safety to decide if restricting their use is necessary. The move was requested by France, which wants to limit the newer contraceptives' use due to blood clots. "There is no reason for any woman to stop taking her contraceptive," the EMA said. "If a woman has concerns, she can discuss this with her doctor." Reuters (1/28), PharmaTimes (U.K.) (1/29) Email this Story
  • France to study deaths linked to acne drug
    Health authorities in France are examining four thrombosis-caused deaths over the past 25 years that may be connected to the acne drug Diane-35, which is also used as a contraceptive. Diane-35, produced by Bayer, is sold in at least 116 countries. Reuters (1/27) Email this Story
  • Report: China needs stronger standards for generic biologics
    A report by the Pharmaceutical Association Committee criticizes China for its lax standards in approving generic versions of biological drugs, pointing out that generics can be registered as new products with lower testing requirements than the originals. "This regulation framework is inconsistent with global norms and can expose patients to unknown risk,” the report asserts. Bloomberg (1/28) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • EU approves lower-profile components of Gore's stent-graft
    European regulators have granted W.L. Gore & Associates CE mark approval to market lower-profile components of its Gore Excluder AAA endoprosthesis, which is used to treat patients with abdominal aortic aneurysms. The approval applies to a 32-millimeter aortic extender and an ipsilateral leg that measures 31 millimeters in diameter. (Boston) (1/25) Email this Story
  FDLI Items 
  • Cosmetics Regulatory Process Primer -- Instant access, purchase and download now
    The Cosmetics Regulatory Process primer provides a baseline of key legal concepts and issues from experts in the field; describing, in detail, the basis of the underlying standards governing cosmetics and how cosmetic oversight differs from the regulation of food, drugs or medical devices. With this basic guide, readers will develop a firm grasp of the legal and regulatory concepts for cosmetics. Other available primers include:
    • The Medical Device Review Process: A Focus on Pre-Market Requirements
    • Controlled Substances: FDA and DEA Regulation of Pharmaceuticals
    Email this Story

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