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March 18, 2013News for the food and drug law community

  Drugs & Biologics 
  • Sequestration threatens faster FDA reviews, Hamburg says
    Across-the-board sequestration cuts could hurt the FDA's efforts to accelerate new drug reviews, said FDA Commissioner Dr. Margaret Hamburg during MassBio's annual meeting. Hamburg said she hopes Congress will allow the agency to put user fees paid by drugmakers toward its operating expenses. Boston Herald (3/15) Email this Story
  • 4 FDA drug decisions on the horizon
    The FDA is poised to decide on Biogen Idec's multiple sclerosis drug BG-12 by March 28, while United Therapeutics is set to receive a verdict by March 31 for the lung drug Remodulin. Johnson & Johnson's diabetes drug Invokana and Map Pharmaceuticals' migraine drug Levadex are also set to receive federal decisions by March 31 and April 15, respectively. Investor's Business Daily (3/15) Email this Story
  • "Design defect" suit threatens FDA review process
    The "design defect" theory behind a lawsuit against generic-drug-maker Mutual Pharmaceutical could result in a wave of lawsuits second-guessing the approval of any drug, former FDA Deputy Commissioner Dr. Scott Gottlieb writes. "The theory would allow state juries to relitigate the risk-benefit analysis that is at the very core of the FDA's authority to approve prescription drugs," he writes. Politico (Washington, D.C.) (3/17) Email this Story
  Food & Dietary Supplements 
  • USDA's Merrigan announces resignation
    Kathleen Merrigan, an advocate for locally produced food and the leader of the "Know Your Farmer, Know Your Food" initiative, announced on Thursday that she will be leaving her post as deputy secretary of the U.S. Department of Agriculture. She did not set a date for her departure, but a department spokesperson said she would remain in the position through the end of April. (3/15) Email this Story
  • Lawmaker relaunches bill that would cut antibiotic use in livestock
    The Preservation of Antibiotics for Medical Treatment Act, a bill first introduced in 2007 to limit the nontherapeutic uses of antibiotics in food animals, has been relaunched by Rep. Louise Slaughter, D-N.Y. The new bill defines what is deemed nontherapeutic and would add cephalosporins to the types of antibiotics that would be restricted from nontherapeutic uses. (3/15) Email this Story
  Medical Devices 
  • FDA warns Hospira over problems at N.C. plant
    Hospira has received an FDA warning citing 20 issues found at its facility in Rocky Mount, N.C., after a three-week inspection. The company, which develops infusion systems and injectable drugs, said it is cooperating with the FDA regarding the matter and will respond to the findings with a plan for remediation and modernization. (Boston) (3/14) Email this Story
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Top five news stories selected by FDLI SmartBrief readers in the past week.

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  FDLI Items 
  • 2013 conference calendar -- speak, register and 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:
    • New European Union Medical Device Regulations: An FDLI Webinar | March 28
    • Controlled Substances Regulation | March 28 | 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.
    • China-U.S. Updates in Food and Drug Law | June 6-7 | Beijing, China
    • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
    • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | New York City
    • 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 General Counsel - RegulatoryUCB, Inc.Atlanta, GA
FDA/Healthcare AssociateArnold & Porter LLPWashington, DC, DC
Associate Director, Regulatory Affairs CelgeneGreater New York City Area, NY
Project Manager, Drug Safety and InnovationThe Pew Charitable TrustsWashington, DC
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