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February 11, 2013News for the food and drug law community

  Drugs & Biologics 
  • Report: Potential cuts are threat to FDA's future success
    Possible cuts to FDA funds are the primary obstacle to the agency's ability to do its job well, according to this blog post. The task at hand is to expand and preserve financial support for the FDA. Poor funding is a weakness for the agency and a threat to the public's well-being, Steven Grossman writes. FDA Matters blog (2/7) Email this Story
  • Celgene's multiple myeloma drug Pomalyst wins FDA approval
    The FDA has approved Celgene's Pomalyst, or pomalidomide, as treatment for patients with multiple myeloma who have stopped responding to other therapies. Pomalyst is intended to strengthen the immune system in blocking and eliminating cancer cells. The drug's label will include a warning that it can cause clots and that it should not be used by pregnant women because of the risk for birth defects. HealthDay News (2/8), Reuters (2/8) Email this Story
  • Macleods gets FDA nod for generic Actos
    Macleods Pharma received FDA approval for its pioglitazone hydrochloride tablets in three strengths: 15 mg, 30 mg and 45 mg. The drug is a generic formulation of the diabetes treatment Actos, made by Takeda. Drug Store News (2/8) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  Medical Devices 
  • FDA submits device data gathering proposal for OMB review
    The FDA has submitted for approval by the Office of Management and Budget a proposal to renew its program for gathering data about medical devices as part of its system to identify and ban devices that are harmful or risky. The agency also is requesting public comment on its process for banning medical technologies. MassDevice.com (Boston) (2/8) Email this Story
  • Zoll gets FDA OK for fully automatic external defibrillator
    The FDA has given Zoll Medical, an Asahi Kasei unit, 510(k) clearance to market its AED Plus system. The newly approved automated external defibrillator, which improves on the semi-automatic version, enables emergency responders to help victims of sudden cardiac arrest by allowing them to preprogram a shock, rather than pressing the "shock" button. MassDevice.com (Boston) (2/8) Email this Story
  Hot Topics 

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

  • Results based on number of times each story was clicked by readers.
  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:
    • Pharmacy Compounding: An FDLI Dialogue | Feb. 12 | Washington, D.C., or via teleconference. Last chance to register!
    • 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.
    Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
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  SmartQuote 
If Columbus had an advisory committee he would probably still be at the dock."
--Arthur Goldberg,
American statesman and jurist


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