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November 30, 2012News for the food and drug law community

  Drugs & Biologics 
  • Mylan gets FDA nod for generic Detrol
    Mylan received regulatory approval for its tolterodine tartrate tablets in the 1-mg and 2-mg strengths to treat overactive bladder. The drug is the generic formulation of Pharmacia and Upjohn's Detrol. Drug Store News (11/29) Email this Story
  • Public Citizen asks FDA to reinspect compounding pharmacies
    Consumer advocacy group Public Citizen urged the FDA to reinspect compounding pharmacies that have received warning letters or to otherwise verify that the issues cited in those warning letters have been corrected. The New England Compounding Center continued to mass produce treatments in an unsterile environment after getting at least one warning letter from the agency. "The FDA has fostered a weak regulatory environment and encouraged pharmacies in the false belief that they are somehow exempt from the laws set in place to ensure the quality of our nation's drug supply," Public Citizen told FDA Commissioner Dr. Margaret Hamburg in a letter. The Hill/Healthwatch blog (11/29) Email this Story
  Global Focus 
  • Quebec axes reimbursement law for branded drugs
    Quebec is removing the 15-year rule authorizing reimbursement for innovative medicines supplied through its public prescription drug insurance plans despite the availability of generics and after expiry of their patents. Abolishing the rule will help save the government more than $176 million annually, the Canadian Generic Pharmaceutical Association said. "Increased utilization of generic prescription drugs is vital to control rising health care costs and ensure the sustainability of public and private drug benefit plans across Canada," CGPA president Jim Keon said. PharmaTimes (U.K.) (11/29) Email this Story
  Food & Dietary Supplements 
  • 3 lawmakers seek inclusion of seafood safety in TPP negotiation
    Rep. Walter Jones, R-N.C., Rep. Rosa DeLauro, D-Conn., and Sen. Mary Landrieu, D-La., wrote to U.S. Trade Representative Ron Kirk asking for the inclusion of public health in negotiations for the Trans-Pacific Partnership Free Trade Agreement. The lawmakers are worried that expanded trade with Malaysia and Vietnam, two countries in the partnership, will result in a rise in contaminated imported seafood. FoodSafetyNews.com (11/30) Email this Story
  Medical Devices 
  • European Commission gets new health leader
    The European Commission has confirmed Tonio Borg, Malta's deputy prime minister and foreign minister, as its new health commissioner, replacing John Dalli. Borg will oversee the commission's regulatory programs involving drugs, medical devices and other industries through Oct. 31, 2014. Clinica (subscription required) (11/29) Email this Story
  FDLI Items 
  • Last day to save: 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 Dec. 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

  • Network at FDLI's Annual Holiday & Leadership Awards Reception -- Dec. 12
     
    Each year the Food and Drug Law Institute recognizes up to four individuals from various areas of the food and drug law community for their notable service and leadership to receive the Distinguished Service and Leadership Award. FDLI members attend the Annual Holiday and Leadership Awards Reception where the recipients are recognized. The Dec. 12 reception will be held 5:30-7 p.m. at The Westin Georgetown in Washington, D.C. FDLI members: Register online. Not a member of FDLI? To join us, e-mail Lauren Roberts, FDLI's membership manager. She will register you, and share information about the benefits of joining the Institute. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
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There's a bit of magic in everything, and some loss to even things out."
--Lou Reed,
American musician


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