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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
How Much Do You Really Need to Make? The Answer May Shock You
Rather than focus on what you can afford to pull out of the business to cover your living expenses, you need to focus on how much you need to earn at your business in order to afford the lifestyle you want to have. This is where the Personal Earnings Goal, or PEG, comes into play. Learn how to calculate your PEG and find out how much you really need to make.

  Global Focus 
 
Building Workplace Trust 2015
Interaction Associates' 6th annual research study tracking trust on the job, Building Workplace Trust, is out, and more than half of employees surveyed give their organizations low marks for trust and leadership. Yet this year's findings again point to how high trust leads to better outcomes and financial results — and even boosts innovation.

  Food & Dietary Supplements 
 
Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

  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
 
The IDC Market Spotlight on Network Automation and Agility
The arrival of virtualization, cloud computing, and mobility has strained data center networks—and IT staff—like never before. This Market Spotlight explains how data center network fabrics provide a foundation for automated provisioning, configuration, and management of network-based services in a new era of IT agility. Download now.

  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
Click here to view more job listings.

  SmartQuote 
It is with words as with sunbeams -- the more they are condensed, the deeper they burn."
--Robert Southey,
British poet


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