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December 31, 2012News for the food and drug law community

  Drugs & Biologics 
  • FDA practice will change if high court affirms off-label ruling
    The Supreme Court could fundamentally alter a system designed to protect Americans from bad drugs if it affirms a federal appeals court decision protecting the off-label promotion of drugs, according to this article. The government has not decided whether to appeal the ruling, according to the Justice Department. PhRMA said "as the Supreme Court, and now the Second Circuit, have recently affirmed, speech by biopharmaceutical companies is protected by the First Amendment, and any policy that restricts speech by biopharmaceutical companies, while allowing others to freely engage in similar speech, is subject to heightened constitutional scrutiny." The Philadelphia Inquirer (12/29) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • FDA recalls 2 ventilator models
    The FDA has recalled two ventilator-related devices. The Ventlab manual resuscitator was found to have a potentially leaking valve that could result in little or no airflow to the patient. The Bunnell Life Pulse High-Frequency Ventilator Patient Circuit, used for critically ill infants, has heater wire insulation that can melt, causing sparking and smoke. MedPage Today (free registration) (12/26) Email this Story
  • Coaxia's NeuroFlo catheter undergoes FDA panel review
    An FDA panel recently met to consider CoAxia's de novo application for use of its NeuroFlo catheter within 14 hours after symptoms begin to show in ischemic stroke patients who aren't fit to receive thrombectomy or tissue plasminogen activator. The device, which already has 510(k) clearance, is used to control or halt the flow of blood in peripheral vessels. Medscape (free registration) (12/28) Email this Story
  Hot Topics 

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

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  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

Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Senior Counsel – Medical Device/Combination ProductAmgenThousand Oaks, CA
Counsel, Advertising and PromotionsMylan Pharmaceuticals Inc.Basking Ridge, NJ
Assistant Commissioner for Compliance PolicyFood and Drug AdministrationSilver Spring, MD
Associate Commissioner for Regulatory AffairsFood and Drug AdministrationSilver Spring, MD
Assistant Commissioner for Compliance PolicyFood and Drug AdminstrationSilver Spring, MD
Sr. Manager, Regulatory Affairs-Promotional ReviewNovo NordiskPrinceton, NJ
Click here to view more job listings.

  Editor's Note 
  • SmartBrief will not publish Tuesday
    In observance of New Year's Day, SmartBrief will not publish Tuesday. Publication will resume Wednesday. Enjoy the holiday! Email this Story
New Year's Day is every man's birthday."
--Charles Lamb,
English essayist

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