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January 24, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA: Low prices contribute to generic drug shortages
    Competition within the generic drug market that keeps prices low also contributes to injectable drug shortages, an FDA report says. Generics manufacturers may try to keep their costs low by cutting corners on quality control, and few generics makers have backup manufacturing facilities available in the event that quality issues halt production, FDA officials said. The Medicare Modernization Act of 2005 lowered reimbursement rates for generic sterile injectable drugs and might have had a role in shortages, they said. MedPage Today (free registration) (1/23) Email this Story
  • Celgene seeks FDA approval of Abraxane for pancreatic cancer
    Celgene plans to submit Abraxane, or paclitaxel, within the next five months for FDA approval as a treatment for pancreatic cancer after obtaining promising results from a Phase III study. Patients with advanced pancreatic cancer who took Abraxane, in combination with gemcitabine, had median overall survival of 8.5 months versus 6.7 months for those given gemcitabine alone. Abraxane is already cleared for lung and breast cancer. Reuters (1/22) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  Medical Devices 
  • Welch Allyn's iPhone-based eye testing tool gets FDA OK
    Welch Allyn has secured 510(k) clearance from the FDA to market a device that links an ophthalmoscope, which is used to spot glaucoma and other eye conditions, with an iPhone. The iExaminer Adapter comes with a companion iPhone application to enable the sharing and printing of images. MedCityNews.com (1/23) 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 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:
    • Food Week 2013 | Feb. 5-8 | Washington, D.C.
    • 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, China
    • 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
FDA AssociateK&L GatesWashington, DC
Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier CorporationAustin, TX
Compliance Counsel - PrivacyOtsukaPrinceton, NJ
Corporate AttorneyOtsukaRockville, MD
Corporate AttorneyOtsukaPrinceton, NJ
Food and Drug AssociateHunton & Williams LLPWashington, DC
Regulatory ConsultantThe Weinberg GroupWashington, DC
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  SmartQuote 
An exaggeration is a truth that has lost its temper."
--Kahlil Gibran,
Lebanese-American artist, poet and writer


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