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February 14, 2013News for the food and drug law community

  Drugs & Biologics 
  Global Focus 
  • Sweden aligns medtech software policies with EU rules
    The Swedish Medical Products Agency has released new guidance outlining its process for regulating standalone software classified as medical devices in the country. The revised guidance is intended to clear up "remaining ambiguities" involving the regulation of such products as well as align it with the European Commission's rules on medtech software. Clinica (subscription required) (2/11) Email this Story
  Food & Dietary Supplements 
  • FDA extends comment period for biotech salmon
    The FDA extended until April 26 the public comment period for AquaBounty Technologies' biotech salmon, which grows twice as fast as traditional fish, after receiving nearly 30,000 responses so far. The agency will evaluate the comments and consider how to proceed, FDA spokesperson Morgan Liscinsky said. Preliminary assessments said no major environmental impact was posed by the fish. Canadian Press (2/13) Email this Story
  Medical Devices 
  • FDA issues notice to Hospira over medical device issues
    Hospira said it has received a notice from the FDA over certain quality concerns involving its medical devices. CEO F. Michael Ball said that while inspectors noted progress had been made, "there is still a lot of work to be done within our device operations." Reuters (2/13) Email this Story
  FDLI Items 
  • 2013 conference calendar -- speak, register & save the dates!
    There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail 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:
    • 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 6-7 | Beijing, China. New date!
    • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
    • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Location TBD
    • FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
    • Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
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Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier CorporationAustin, TX
FDA AssociateK&L GatesMultiple Locations, United States
Food and Drug AssociateHunton & Williams LLPWashington, DC
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Continuity gives us roots; change gives us branches, letting us stretch and grow and reach new heights."
--Pauline Kezer,
American politician

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