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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
Get It Right: Pricing Strategies That Work
Many entrepreneurs hope for success by offering low prices, while in fact most world-class entrepreneurs succeed by setting higher prices. If you're not exactly sure which pricing strategy will work for your business, these 6 steps can help you set your company's prices for success. Read the exclusive article now.

  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    Health Canada unveiled a draft guidance regarding the use of data from similar foreign regulatory agencies such as the European Medicines Agency and the FDA.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

Time and Attendance: The Core of Managing and Measuring Your Workforce
Based on data from Brandon Hall Group's 2014 Workforce Management Study, this paper explores the evolution of time and attendance, the impact of automation and integration, and the key role time and attendance solutions play in managing and measuring today's workforce. Read the Paper and Learn More

  Food & Dietary Supplements 
 
Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

  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
How to Achieve IT Agility: A Survival Guide for IT Decision Makers
When business teams add new apps and services to already-strained networks, IT departments are accountable for making everything work. Is your team ready for this challenge? Read this eGuide to learn how IT teams are automating their networks, why they're utilizing Ethernet fabrics and SDN, and what success looks like as they regain network control and business relevance.

  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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  SmartQuote 
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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