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

  Drugs & Biologics 
  • Congress hears from many over regulation of compounders
    As Congress begins to consider changes in the regulation of specialty pharmacies, drugmakers are calling for oversight or limits for compounders that act as mass producers or make "knockoff" medications for humans and animals. Hospitals want to avoid regulations that exacerbate drug shortages. The Washington Post (3/2) Email this Story
  • EU approves Roche's Perjeta for metastatic breast cancer
    The European Medicines Agency OK'd Roche Holding's Perjeta, or pertuzumab, in combination with trastuzumab and docetaxel, to treat women with previously untreated HER2-positive metastatic breast cancer. The approval followed the release of data from a late-stage trial, which showed that patients who took a combination of Perjeta, trastuzumab and chemotherapy survived 6.1 months longer without their disease progressing than those who received trastuzumab and chemotherapy. Fox Business/Dow Jones Newswires (3/5) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  Medical Devices 
  • FDA OKs Bluetooth-enabled blood glucose monitor from LifeScan
    LifeScan has received FDA approval for its OneTouch Verio Synch system, which is used to monitor blood glucose in diabetes patients. The technology uses Bluetooth connectivity to allow patients to wirelessly receive personalized data, including a 14-day summary of glucose test outcomes, via an iPad, iPhone or iPod touch. Healio/Endocrine Today (3/4) Email this Story
  • FDA examines complications tied to Intuitive's surgical robot
    The FDA reportedly is conducting a survey on complications experienced by doctors in using Intuitive Surgical's da Vinci surgical robot after receiving increased incident reports tied to the device. Doctors in the survey also were asked about the training they obtained in using the technology as well as about procedures that may or may not be ideal for the device. MassDevice.com (Boston) (3/1) Email this Story
  • AdvaMed CEO raises concerns over fallout from sequestration
    The FDA's budget and the user fees paid by the medtech industry will be affected by the automatic budget cuts known as sequestration, said AdvaMed President Stephen Ubl, who adds that his group is working to make a case about the adverse effects of those cuts. Ubl also expressed concern that political distractions are complicating industry efforts to strike down the medical device tax. "It clearly makes it harder to focus individual members [of Congress] on the harmful impacts of the tax," he said, "[But] I think we’re off to a very strong start this year." Star Tribune (Minneapolis-St. Paul, Minn.) (3/2) 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:
    • 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

 
Position TitleCompany NameLocation
Associate Director, Regulatory Affairs CelgeneGreater New York City Area, NY
Project Manager, Drug Safety and InnovationThe Pew Charitable TrustsWashington, DC
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
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