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November 28, 2012News for the food and drug law community

  Drugs & Biologics 
  • Wockhardt gets three generic-drug approvals from FDA
    The FDA has granted Wockhardt approval for its generic version of Bristol-Myers Squibb's and Sanofi's anticoagulant Plavix. The company has also received approvals for its generic copies of GlaxoSmithKline's antidepressant drug Wellbutrin SR and Novartis' Parkinson's disease drug Stalevo. Drug Store News (11/27) Email this Story
  • Bayer-Regeneron drug Eylea gets EU OK for wet AMD
    Bayer HealthCare and Regeneron Pharmaceuticals' eye drug Eylea, or aflibercept, obtained approval from the European Commission to treat neovascular age-related macular degeneration. The drug will be launched shortly in Europe to compete with Novartis' wet AMD treatment Lucentis, or ranibizumab. PharmaTimes (U.K.) (11/27) Email this Story
  • Opinion: Invest in CDC to guarantee public health, economic security
    Lawmakers should invest in the CDC instead of cutting its budget to ensure the public's health and the country's economic security, six former CDC directors write. There is consensus on the essential role of the government in preventing epidemics and minimizing the damage in events such as the meningitis outbreak tied to steroids from a Massachusetts drug compounder. Ensuring that the agency is well-resourced is a nonpartisan issue, the directors write. Politico (Washington, D.C.) (11/27) Email this Story
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A roadmap for increasing your influence at work. Learn more through insights from Kellogg School of Management Professor Harry Kraemer.
  Global Focus 
  • Canadian pharma will not oppose law increasing access to generics
    Drugmakers in Canada will not oppose the amendments proposed to Bill C-398 designed to increase the availability of generic drugs in impoverished countries, Canada's Research-Based Pharmaceutical Companies President Russell Williams wrote in a letter to the House of Commons. The reforms should comply with the rules of the World Trade Organization, Williams wrote. The Globe and Mail (Toronto) (tiered subscription model) (11/26) Email this Story
  Food & Dietary Supplements 
  • Two senators applaud FDA action on energy drinks
    Sens. Richard Blumenthal, D-Conn., and Dick Durbin, D-Ill., praised the decision of the FDA to examine the safety of energy drinks, which contain high caffeine levels. The advice of outside experts is likely to be sought to help identify if the drinks pose specific risks to teenagers or people with health conditions, the FDA said in letter. "I am glad to see that the FDA is undertaking a review but more needs to be done and quickly," the senators said. "For instance, FDA can and should take action now to regulate energy drinks that are marketed as beverages." The Hill/Floor Action Blog (11/27), The New York Times (tiered subscription model) (11/27) Email this Story
  Medical Devices 
  • GE gets FDA OK for liver embolization imaging device
    The FDA has given GE Healthcare 510(k) clearance to market its FlightPlan for Liver imaging tool, which aids in planning liver embolization procedures. The device, which already is being marketed in Asia, Europe and Latin America, creates a 3D road map of tumor-feeding blood vessels to help doctors direct a catheter to the targeted artery. (Boston) (11/27) Email this Story
  • Court: Tobacco firms must tell public they lied
    U.S. District Judge Gladys Kessler ruled Tuesday that major tobacco companies must pay for their own public advertising campaign saying they lied about the dangers of cigarettes. The campaign, Kessler writes, would be suitable to counter the companies' deception in the past, which dates back to at least 1964. Reuters (11/27) Email this Story
  FDLI Items 
  • FDLI Annual Conference Call for Sessions: Submit a Proposal by Dec. 7
    FDLI will host its 56th Annual Conference on April 23-24 in Washington, D.C. This event, attended by a large and diverse cross-section of food and drug law professionals, has risen to prominence throughout almost six decades because of the contributions from the food and drug law community. We invite you to submit a proposal for a general or breakout session. Submit your proposal online no later than Dec. 7. Proposal submission does not guarantee selection. Email this Story

  • Early-bird ends Friday: Register for Enforcement, Litigation, and Compliance Conference
    Whether you are a regulator, litigator, compliance specialist or consultant, it is critical to stay current on the changing trends in enforcement, litigation, and compliance. Don’t miss this December 12-13 conference. Register. Keynote sessions and speakers:
    • The New Faces of Enforcement: Gregory Demske, chief counsel to the inspector general, HHS.
    • Hear Directly from FDA's Office of Regulatory Affairs: Howard Sklamberg, deputy associate commissioner for regulatory affairs, ORA, FDA.
    • Litigation and Settlements: What You Really Need to Know: Neil H. MacBride, U.S. attorney for the Eastern District of Virginia.
    Email this Story
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If only we'd stop trying to be happy we could have a pretty good time."
--Edith Wharton,
American writer

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