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February 12, 2013News for the food and drug law community

  Drugs & Biologics 
  • Footnote in court hints at new FDA rules for generic warnings
    The FDA may revise regulations so that makers of generic drugs can update labels to warn patients about risks, Ed Silverman writes. The Justice Department filed a friend-of-court brief in a case concerning generic drugs, and it carried this footnote: "This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances." Pharmalot.com/Pharma Blog (2/11) Email this Story
  • Early trials may be enough for innovative drugs to win FDA approval
    The FDA granted "breakthrough" status to three promising experimental drugs as part of efforts to speed market entry for treatments of life-threatening conditions. "We expect many of these would come available very quickly with Phase 1 data," FDA Center for Drug Evaluation and Research Director Janet Woodcock said. Applications for breakthrough status have been made for 18 other treatments, she said. Bloomberg Businessweek (2/12) Email this Story
10 ways to inspire creativity in your staff.
Fostering creative business practices isn't as hard as it seems and can lead to smart solutions. Use these ten techniques to help inspire and encourage creativity in your staff. Read the article and learn 10 ways to get the creative juices flowing.

  Food & Dietary Supplements 
 
  • Supreme Court to hear case on genetically modified soybeans
    A Supreme Court case could determine whether Monsanto and other seed producers can prevent farmers from re-planting genetically altered crops. An Indiana farmer bought progeny soybeans from a grain elevator for planting. A ruling against Monsanto "would devastate innovation in biotechnology," according to the company's brief. The Washington Post (2/9) Email this Story
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.

  Medical Devices 
 
  • Optovue scores 510(k) clearance for OCT system database
    Optovue has been cleared by the FDA to incorporate a normative database into the firm's iVue spectral-domain optical coherence tomography device. The iVue SD-OCT technology can use the database to enable the quantitative comparisons of the optic disc and other areas of the eye, as well as tailor OCT scans according to a patient's age, optic disc size and other factors. Healio (2/8) Email this Story
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.

  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.
    Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
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Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
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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  SmartQuote 
Do not teach your children never to be angry; teach them how to be angry."
--Lyman Abbott,
American theologian, author and editor


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