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February 13, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA updates watch list by adding 3 drugs
    The FDA added GlaxoSmithKline's leukemia drug Arzerra, or ofatumumab; UCB's epilepsy, liver and kidney drug Vimpat, or lacosamide; and Acorda Therapeutics' multiple sclerosis, kidney and liver drug Ampyra, or dalfampridine, to its list of products to monitor due to new safety information or possible signs of serious risks. The FDA received reports of potential adverse events involving the treatments in last year's third quarter. A sunscreen was also added to the list. Medscape (free registration) (2/12) Email this Story
  • EU hastens metastatic melanoma review for GSK drugs
    The European Medicines Agency granted GlaxoSmithKline's request for accelerated review of trametinib as a monotherapy and in combination with dabrafenib for metastatic or unresectable melanoma in people with the BRAF V600 mutation. The accelerated schedule could make the drugs available within six months. PharmaTimes (U.K.) (2/12) Email this Story
Is Pricing Low Your Strategy to Success? Think again.
Pricing is the heart of a business. It affects everything you do and is affected by everything you do. Economists talk of supply and demand as key factors behind pricing—successful entrepreneurs manipulate demand by making their products more desirable. These six steps will help you determine the right price for your product or service, read the article and learn how to get pricing right.

  Global Focus 
  • CurveBeam gains EU approval for foot and ankle CT scanner
    European regulators have granted CurveBeam approval to market its PedCAT CT scanner, which is used to generate 3D foot and ankle images during weight- and nonweight-bearing evaluations for preoperative planning and other applications. The device uses cone-beam technology, which allows it to deliver a lower radiation dose than conventional CT systems and be small enough to fit in a doctor's office. (2/12) Email this Story
  • Japan loosens stability testing requirements for devices
    Japan will no longer require medtech companies to include stability testing data in order to get approval for devices after a Regulatory Task Force agreed the requirements could be eliminated in most cases. The task force is made up of representatives of the country's Ministry of Health, Labour and Welfare and the medical device industry. The move is meant to alleviate the delay in medical device approval in Japan, but some devices still require the data, including those that contain certain raw materials, biological products and radioactive material. Clinica (subscription required) (2/11) Email this Story
SHRM Exec Study: Impact of Absence
Read the compelling results of this 2014 survey conducted by SHRM and Kronos® that demonstrate how a clearly defined strategy to monitor and manage absence, with proper training and automation, can help control costs associated with absences and improve your bottom line. Click here to learn more.

  Food & Dietary Supplements 
  • FDA examines pet treats from China
    The FDA is investigating whether Chinese production of jerky treats for pets has been a factor in reports of dog illnesses. The FDA also found that some of the treats have chicken that is not approved in the U.S. to be consumed by humans due to issues related to conditions in the factories in China. The Wall Street Journal (2/13) Email this Story
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 
Whitepaper: SDN: How do you get there from here?
Are the growing data needs of mobile, cloud, big data and social threatening today's enterprise networks? Scalable processes, a phased integration approach and the appetite to optimize over time are key components of a modern network. It's how agile organizations prepare for the data needs of tomorrow.
Explore the whitepaper to start down the path toward SDN.

  FDLI Items 
  • Advanced Medical Device Compliance, Regulation and Litigation Conference -- March 4
    At this conference, now in its second year, attendees will hear Carolyn "Cassie" Scherer, policy adviser, Office of the Center Director, CDRH, FDA, and Mary Weick-Brady, senior policy adviser, Office of the Center Director, CDRH, FDA, discuss in detail the most significant recent and upcoming medical device compliance, regulatory and enforcement actions. Additionally, legal experts will analyze the most important cases of 2012 and detail what to expect in 2013 in litigation and regulatory developments, including key products liability issues. Register now. Email this Story

  • Registration now open -- Introduction to Medical Device Law and Regulation
    Hear from experts who will review the essential elements of FDA medical device regulation in a systematic and comprehensive way during this two-day interactive program. Experts in the field will help you:
    • Learn FDA's organizational structure and pre-market requirements.
    • Understand postmarket requirements, Quality System Regulation (QSR), adverse reporting, and advertising and promotion.
    • Prepare a successful 510(k) submission.
    • Identify new and developing FDA policies and procedures affecting all phases of medical device regulation.
    Register now to save $100. April 3-4 | Washington, D.C. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier CorporationAustin, TX
FDA AssociateK&L GatesMultiple Locations, United States
Food and Drug AssociateHunton & Williams LLPWashington, DC
Click here to view more job listings.

Every individual has a place to fill in the world and is important in some respect whether he chooses to be so or not."
--Nathaniel Hawthorne,
American author

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