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February 5, 2013News for the food and drug law community

  Drugs & Biologics 
  • Zealand-Sanofi diabetes drug wins go-ahead in Europe
    Sanofi and Zealand Pharma obtained approval from the European Commision to market the drug Lyxumia, or lixisenatide, for treatment of diabetes. The prandial GLP-1 receptor agonist will be used with oral glucose-lowering treatments and/or basal insulin to control blood sugar levels. PharmaTimes (U.K.) (2/4) Email this Story
  • FDA rejects Hemispherx's Ampligen as treatment for CFS
    The FDA didn't approve Hemispherx Biopharma's application for its candidate chronic fatigue syndrome drug Ampligen. The drugmaker will seek an "end-of-review" meeting with regulators and could file a formal appeal. Hemispherx said the agency requested data analyses, the completion of nonclinical trials and at least one more study involving patients. Reuters (2/4) Email this Story
  • Some CME payments exempt from Sunshine Act disclosure
    Drugmakers and medical-device makers will not be required under the Sunshine Act to disclose payments to speakers at continuing medical education events who they did not select or pay directly. The decision to exempt indirect speaker payments is "good common sense," says Coalition for Healthcare Communication executive director John Kamp. Pharmalot.com/Pharma Blog (2/4) Email this Story
How Much Do You Really Need to Make? The Answer May Shock You
Rather than focus on what you can afford to pull out of the business to cover your living expenses, you need to focus on how much you need to earn at your business in order to afford the lifestyle you want to have. This is where the Personal Earnings Goal, or PEG, comes into play. Learn how to calculate your PEG and find out how much you really need to make.

  Food & Dietary Supplements 
  • Rule widens FDA power to keep unsafe food from market
    The FDA introduced a final rule that allows the agency the ability to keep adulterated or mislabeled food from being sold. "The agency can keep the products out of the marketplace for a maximum of 30 days while the agency determines whether to take further enforcement action, such as seizure," the FDA said. FoodSafetyNews.com (2/4) Email this Story
  Medical Devices 
  • FDA OKs MRI device as companion Dx for iron overload drug
    Resonance Health has received the FDA's OK for its FerriScan R2-MRI system to be sold as a companion diagnostic for Novartis drug Exjade, which is used to treat iron overload in patients suffering from genetic blood disorders. The device is intended to help pinpoint which patients with nontransfusion-dependent thalassemia would best benefit from the drug. AuntMinnie.com (free registration) (2/4) Email this Story
  Tobacco 
  • FDA doing too little with its power to regulate tobacco
    Last year, a report found, the FDA slowed the march of new regulations for tobacco. The agency says it was consolidating enforcement of regulations added since the signing of the Tobacco Control Act. It's time for more progress from the agency, as well as from Congress and states, according to this editorial. The Washington Post (2/4) Email this Story
 
  FDLI Items 
  • 2013 conference calendar announced -- speak, register & save the dates!
    There are plenty of speaking opportunities available for this year's FDLI conferences. Please email our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
    • Pharmacy Compounding: An FDLI Dialogue | Feb. 12 | Washington, D.C., or via teleconference
    • Medical Device Compliance, Regulation and Litigation Conference | March 4 | Washington, D.C.
    • Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
    • Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
    • FDLI Annual Conference | April 23-24 | Washington, D.C.
    • FDLI International Conference | June 10-11 | Beijing
    • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
    • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Washington, D.C.
    • FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
    • Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
    Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
Position TitleCompany NameLocation
Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier CorporationAustin, TX
FDA AssociateK&L GatesMultiple Locations, United States
FDA/ORA/Asst Commissioner for Operations, Food and Drug Administration, Office of Regulatory AffairsFood and Drug AdministrationRockville, MD
FDA/ORA/Regional Food and Drug DirectorFood and Drug Administration/Office of Regulatory AffairsMultiple Locations, United States
Food and Drug AssociateHunton & Williams LLPWashington, DC
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  SmartQuote 
Our business in life is not to succeed, but to continue to fail in good spirits."
--Robert Louis Stevenson,
Scottish novelist, poet and essayist


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