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January 22, 2013News for the food and drug law community

  Drugs & Biologics 
  • ThromboGenics' eye drug Jetrea wins EU panel support
    ThromboGenics' Jetrea, or ocriplasmin, was recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use as a treatment for vitreomacular adhesion. The recommendation brings ThromboGenics one step nearer to $120 million in milestone fees from its partner Novartis, which holds the marketing rights to Jetrea outside the U.S. Bloomberg (1/18) Email this Story
  Global Focus 
  • Canadian guidance covers use of foreign data in drug reviews
    Health Canada unveiled a draft guidance regarding the use of data from similar foreign regulatory agencies such as the European Medicines Agency and the FDA. "The Use of Foreign Reviews by Health Canada" covers abbreviated and supplemental new drug submissions, periodic safety update reports, medical device licenses, risk management plans, drug identification number applications and notifiable changes. The guidance aims to establish a framework for more consistent use of foreign reviews in Canada's approval of health products. Financial Post (Canada)/Legal Post blog (1/21) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • Zimmer gets FDA OK for knee replacement guidance system
    The FDA has given Zimmer 510(k) clearance to market its iASSIST Knee system, which is used to guide surgeons during joint replacement procedures. The device, which consists of disposable electronic pod components, helps doctors validate the alignment of knee implants via an electronic display at the surgical site. RTT News (1/17) Email this Story
  • EU approves Integra's diabetes wound management system
    Integra LifeSciences has earned CE mark approval in Europe to market a device used to help patients with diabetes manage their chronic wounds. The Integra Flowable Wound Matrix system, which works by filling deep soft tissue or tunneling wounds, could help reduce the risk of amputation in patients with diabetes. RTT News (1/18) Email this Story
  FDLI Items 
  • FDLI needs your opinion -- Complete 30-second survey and be entered to win $100
    Technology is rapidly changing and FDLI wants to make sure we are leveraging technological advances and delivering our products and services in ways that meet your needs and preferences. We have developed a quick survey of five questions about your online educational preferences (online conferences and e-books). Please fully complete the survey by Friday to be entered to win one of two $100 American Express gift cards. Winners will be identified in a random drawing. Complete the 30 second survey online. (Hit refresh once if the survey doesn't automatically appear and you receive an error message in Internet Explorer.) Your thoughts are very important to us as we consider new technology for serving the food and drug law community. Email this Story
  • Cosmetics Regulatory Process Primer -- Instant access, purchase and download now
    The Cosmetics Regulatory Process primer provides a baseline of key legal concepts and issues from experts in the field; describing, in detail, the basis of the underlying standards governing cosmetics and how cosmetic oversight differs from the regulation of food, drugs or medical devices. With this basic guide, readers will develop a firm grasp of the legal and regulatory concepts for cosmetics. Other available primers include:
    • The Medical Device Review Process: A Focus on Pre-Market Requirements
    • Controlled Substances: FDA and DEA Regulation of Pharmaceuticals
    Email this Story

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It is so difficult not to become vain about one's own good luck."
--Simone de Beauvoir,
French writer and philosopher

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