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February 15, 2013News for the food and drug law community

  Drugs & Biologics 
  • Janssen-Pharmacyclics lymphoma drug gets breakthrough status
    The FDA granted breakthrough therapy status to Janssen Biotech and Pharmacyclics' ibrutinib, a Bruton's tyrosine kinase inhibitor, as a treatment for relapsed or refractory mantle cell lymphoma and Waldenström's macroglobulinemia. The companies plan to submit the drug for approval for mantle cell lymphoma in 2013. PharmaTimes (U.K.) (2/14) Email this Story
  • Analysis: Diclofenac's heart risks warrant caution
    Diclofenac, a nonsteroidal anti-inflammatory drug, was associated with an up to 63% higher risk of cardiovascular events, and should be eliminated from essential-medicines lists, according to a meta-analysis published online in PLoS Medicine. Diclofenac was the most widely used NSAID in 15 countries, and its heart risk was comparable to that of rofecoxib, which was withdrawn from the market due to its cardiovascular toxocicty. TheHeart.org (Montreal) (free registration) (2/13) Email this Story
  • 2 W.Va. lawmakers reintroduce bills against Rx drug abuse
    Rep. Nick Rahall, D-W.Va., and Sen. Jay Rockefeller, D-W.Va., reintroduced bills against the abuse or misuse of prescription drugs. Legislation would bolster funding for drug monitoring programs, establish a uniform reporting system for deaths tied to painkillers and promote patient and physician education. The bills would require health care professionals to meet new training standards for licenses to prescribe such treatments. San Francisco Chronicle/The Associated Press (2/14) Email this Story
  Food & Dietary Supplements 
  • Health officials push FDA for sugar limits
    Public health officials from several U.S. cities including Boston and Los Angeles joined the Center for Science in the Public Interest in urging the Food and Drug Administration to regulate the amount of caloric sweeteners allowed in soft drinks and put voluntary limits on sugar in cereals and packaged snacks. "We felt it was very important for us to make a statement that the FDA should be making policy about what the appropriate level of sugar consumption is," said Lora Lacey-Haun, co-chair of the Kansas City Health Commission. The New York Times (tiered subscription model) (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
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
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In order that people may be happy in their work, these three things are needed: They must be fit for it; they must not do too much of it; and they must have a sense of success in it."
--John Ruskin,
British art critic


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