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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 The FDA issued a draft guidance on kinds of studies to perform to gauge the efficacy of new formulations as well as how the FDA will assess safety claims.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. (1/9) Email this Story
  Global Focus 
  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." (1/10) Email this Story
  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. (1/9) Email this Story
  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

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

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