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February 13, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA updates watch list by adding 3 drugs
    The FDA added GlaxoSmithKline's leukemia drug Arzerra, or ofatumumab; UCB's epilepsy, liver and kidney drug Vimpat, or lacosamide; and Acorda Therapeutics' multiple sclerosis, kidney and liver drug Ampyra, or dalfampridine, to its list of products to monitor due to new safety information or possible signs of serious risks. The FDA received reports of potential adverse events involving the treatments in last year's third quarter. A sunscreen was also added to the list. Medscape (free registration) (2/12) Email this Story
  • EU hastens metastatic melanoma review for GSK drugs
    The European Medicines Agency granted GlaxoSmithKline's request for accelerated review of trametinib as a monotherapy and in combination with dabrafenib for metastatic or unresectable melanoma in people with the BRAF V600 mutation. The accelerated schedule could make the drugs available within six months. PharmaTimes (U.K.) (2/12) Email this Story
  Global Focus 
  • CurveBeam gains EU approval for foot and ankle CT scanner
    European regulators have granted CurveBeam approval to market its PedCAT CT scanner, which is used to generate 3D foot and ankle images during weight- and nonweight-bearing evaluations for preoperative planning and other applications. The device uses cone-beam technology, which allows it to deliver a lower radiation dose than conventional CT systems and be small enough to fit in a doctor's office. MedGadget.com (2/12) Email this Story
  • Japan loosens stability testing requirements for devices
    Japan will no longer require medtech companies to include stability testing data in order to get approval for devices after a Regulatory Task Force agreed the requirements could be eliminated in most cases. The task force is made up of representatives of the country's Ministry of Health, Labour and Welfare and the medical device industry. The move is meant to alleviate the delay in medical device approval in Japan, but some devices still require the data, including those that contain certain raw materials, biological products and radioactive material. Clinica (subscription required) (2/11) Email this Story
  Food & Dietary Supplements 
  • FDA examines pet treats from China
    The FDA is investigating whether Chinese production of jerky treats for pets has been a factor in reports of dog illnesses. The FDA also found that some of the treats have chicken that is not approved in the U.S. to be consumed by humans due to issues related to conditions in the factories in China. The Wall Street Journal (2/13) Email this Story
  Medical Devices 
  FDLI Items 
  • Advanced Medical Device Compliance, Regulation and Litigation Conference -- March 4
      
    At this conference, now in its second year, attendees will hear Carolyn "Cassie" Scherer, policy adviser, Office of the Center Director, CDRH, FDA, and Mary Weick-Brady, senior policy adviser, Office of the Center Director, CDRH, FDA, discuss in detail the most significant recent and upcoming medical device compliance, regulatory and enforcement actions. Additionally, legal experts will analyze the most important cases of 2012 and detail what to expect in 2013 in litigation and regulatory developments, including key products liability issues. Register now. Email this Story

  • Registration now open -- Introduction to Medical Device Law and Regulation
    Hear from experts who will review the essential elements of FDA medical device regulation in a systematic and comprehensive way during this two-day interactive program. Experts in the field will help you:
    • Learn FDA's organizational structure and pre-market requirements.
    • Understand postmarket requirements, Quality System Regulation (QSR), adverse reporting, and advertising and promotion.
    • Prepare a successful 510(k) submission.
    • Identify new and developing FDA policies and procedures affecting all phases of medical device regulation.
    Register now to save $100. April 3-4 | Washington, D.C. Email this Story
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