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January 10, 2013News for the food and drug law community

  Drugs & Biologics 
  • Vertex CF drugs win FDA's first breakthrough therapy designations
    The FDA awarded the first two breakthrough therapy designations to two cystic fibrosis drugs from Vertex Pharmaceuticals. The first designation was given to Kalydeco, or ivacaftor, for potential additional indications. The other designation was granted to a combination of Kalydeco and the experimental drug VX-809. The goal of the breakthrough therapy designation, which was enacted under the 2012 Food and Drug Administration Safety and Innovation Act, is to speed up the development and evaluation of new drugs for serious or life-threatening diseases. PharmaTimes (U.K.) (1/9), Bloomberg (1/9) Email this Story
  • FDA asks drugmakers to study safer painkiller formulations
    The FDA is calling on drugmakers to study drug formulations that would prevent people from abusing treatments, part of an effort to curb the misuse of prescription painkillers. The FDA issued a draft guidance on kinds of studies to perform to gauge the efficacy of new formulations as well as how the FDA will assess safety claims. HealthDay News (1/10) Email this Story
  • Drugmaker fees, orphan-drug charges to rise in EU in 2013
    The European Medicines Agency expects to collect an increasing amount of money in fees from pharmaceutical companies in this year's budget. The agency's spending will total about $302 million this year, a 4% increase from last year. The plan includes about a 10% increase in money raised by fees. The orphan drug fee rate could be increased. In-PharmaTechnologist.com (1/9) Email this Story
10 ways to inspire creativity in your staff.
Fostering creative business practices isn't as hard as it seems and can lead to smart solutions. Use these ten techniques to help inspire and encourage creativity in your staff. Read the article and learn 10 ways to get the creative juices flowing.

  Global Focus 
 
eBook: Why It's Time to Evaluate Your Timekeeping System
Download the free eBook to learn why yesterday's timekeeping tools aren't cut out for today's rapidly evolving compliance mandates. Learn how modern, cloud-based solutions can help you reduce the risk of noncompliance, gain unprecedented visibility, and manage in the moment. Don't let outdated workforce management tools drag you down. Click here to learn more.

  Food & Dietary Supplements 
 
  • FDA warns 2 producers over shell egg regulations
    The FDA has issued warning letters to Midwest Poultry Services and SKS Enterprises over what it says are violations of shell egg regulations. The agency inspected production facilities of Midwest in Ohio and SKS in California and said eggs were produced under "insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health." FoodSafetyNews.com (1/10) 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 
 
  • FDA gives VertiFlex nod on 2 spinal devices
    VertiFlex said it has been cleared by the FDA to market its Totalis device, which is used in minimally invasive procedures for lumbar spine decompression. The agency also cleared the company's UniVise spinal implant, a spinous process fixation device for use in the lumbar spine with fusion. BeckersASC.com (1/9) Email this Story
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 
  • Don't Miss FDLI Food Week 2013: Feb. 5-8 in Washington, D.C.
      
    FDLI's Food Week 2013 program is a unique opportunity for food law, regulation and policy stakeholders to hear first-hand from government officials and industry experts on the latest legal and regulatory developments. Food Week 2013 is a collection of four advanced one-day conferences, as well as FDLI's industry standard "Introduction to Food Law and Regulation" course. At this unique program, you set the menu -- attend one, two, three or all four conferences to make the most of your Food Week 2013 experience. Email this Story

Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
Position TitleCompany NameLocation
Senior Counsel – Medical Device/Combination ProductAmgenThousand Oaks, CA
Compliance Counsel - PrivacyOtsukaPrinceton, NJ
Corporate AttorneyOtsukaRockville, MD
Corporate AttorneyOtsukaPrinceton, NJ
Counsel, Advertising and PromotionsMylan Pharmaceuticals Inc.Basking Ridge, NJ
Sr. Manager, Regulatory Affairs-Promotional ReviewNovo NordiskPrinceton, NJ
Regulatory ConsultantThe Weinberg GroupWashington, DC
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
Click here to view more job listings.

  SmartQuote 
Man is so made that when anything fires his soul, impossibilities vanish."
--Jean de La Fontaine,
French writer and poet


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