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January 2, 2013News for the food and drug law community

  Drugs & Biologics 
  • J&J's tuberculosis drug Sirturo wins FDA approval
    The FDA approved the use of Johnson & Johnson's Sirturo, or bedaquiline, in combination with other drugs, to treat patients with multidrug-resistant tuberculosis. Sirturo, developed by J&J's Janssen Therapeutics, is the first new tuberculosis drug to gain approval in 40 years. Because of the possibility of fatal heart problems, Sirturo will carry a boxed warning. Reuters (12/31), MSN/The Associated Press (12/31) Email this Story
  • Sequestration would have slowed drug approvals, group warned
    The FDA would have lost $318 million of its $4.5 billion budget under automatic spending cuts if Congress hadn't reached a deal on the "fiscal cliff." The Alliance for a Stronger FDA said most of the agency's money goes to paying inspectors, scientists and other workers, so drug approvals and inspections would have suffered because the only way to save would have been to lay off or furlough employees. Forbes (12/31), (1/2) Email this Story
  • 2012's top stories in biotechnology
    Genetic Engineering & Biotechnology News lists nine of the most important developments in the biotech industry for 2012. Among the stories for the year was the FDA's issuance in February of a draft guidance for the development and approval of biosimilar drugs. The threat of cuts as part of the "fiscal cliff" loomed over the budgets of the NIH, FDA, CDC and National Science Foundation. The year ended without a blockbuster merger or acquisition but with more new drug approvals from the FDA than 2011. Genetic Engineering & Biotechnology News (12/31) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • Proposed device ID rule may result in changes to packaging lines
    The FDA's proposal to set up a unique device identifier system for medical technologies will compel firms to modify their packaging lines, which could be costly, according to this article. The FDA Safety and Innovation Act mandates that a final rule on the proposal be issued in the middle of May, not the middle of June as previously thought, but the agency "doesn't seem to be confident of meeting either possible deadline," said Jeffrey Secunda of the Advanced Medical Technology Association. Packaging World online (12/31) Email this Story
  • FDA labels Zimmer recall as Class I
    Medical device developer Zimmer Holdings has been given Class I status from the FDA for a global recall of its PEEK Ardis Inserter instruments over concerns that the devices could lead to problems during surgery, including severe bleeding. The December recall came on the heels of reports that the inserters may put too much pressure on the Ardis Interbody Spacers. The recall covers specific lots distributed from June 2008 to December 2012. (Boston) (1/1) Email this Story
  FDLI Items 
  • Brand new -- Pharmaceutical and Medical Device Compliance Manual, First Edition
    The fight against fraud and abuse in health care programs, and the pharmaceutical and medical device industries in particular, continues to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in health care, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Learn more and purchase the practical guide, Pharmaceutical and Medical Device Compliance Manual. Email this Story

  • Food Safety: Latest Regulatory Developments & Best Practices -- Food Week 2013 -- Feb. 7
    Are you wondering where the industry stands on the mandated guidance and regulation that FDA is expected to promulgate under the Food Safety Modernization Act (FSMA)? FDLI’s Food Safety Conference, taking place during Food Week 2013, will review what has been developed and what is ahead for 2013. Speakers will explore expectations for FSMA's Voluntary Qualified Importer Program, and discuss other upcoming regulations. Looking beyond the specifics of FSMA implementation, speakers will review the food safety dynamics of natural disasters and the business of food safety. Learn more about Food Week 2013. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Senior Counsel – Medical Device/Combination ProductAmgenThousand Oaks, CA
Counsel, Advertising and PromotionsMylan Pharmaceuticals Inc.Basking Ridge, NJ
Assistant Commissioner for Compliance PolicyFood and Drug AdministrationSilver Spring, MD
Associate Commissioner for Regulatory AffairsFood and Drug AdministrationSilver Spring, MD
Assistant Commissioner for Compliance PolicyFood and Drug AdminstrationSilver Spring, MD
Sr. Manager, Regulatory Affairs-Promotional ReviewNovo NordiskPrinceton, NJ
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