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March 7, 2013News for the food and drug law community

  Drugs & Biologics 
  • Regulators extend Pfizer's patent on Celebrex
    The U.S. Patent & Trademark Office extended the patent on Pfizer's Celebrex until Dec. 2, 2015, for arthritis and other conditions, extending market exclusivity by a year and a half. Pfizer filed suit against Teva Pharmaceutical Industries, Mylan, Actavis (formerly Watson), Lupin and Apotex to block U.S. sales of generic versions beginning in May 2014. Reuters (3/5) Email this Story
  • Patent settlements go before Supreme Court on March 25
    Generic and brand-name drugmakers are set for a March 25 Supreme Court case in which federal officials argue that drug prices would be reduced without patent settlements. The case "will define how an entire industry does business," Generic Pharmaceutical Association President Ralph Neas said. An unfavorable ruling will be bad for drugmakers, taxpayers and consumers, he said. The Philadelphia Inquirer (3/6) Email this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Food & Dietary Supplements 
  Medical Devices 
  • Medtronic obtains approval for cardiac leads in Europe
    Medtronic has received the green light in Europe for its Attain Performa line of quadripolar leads, which are used with the company's Viva/Brava cardiac resynchronization therapy defibrillators. The devices are equipped with features that aid doctors in providing personalized care to heart failure patients, a company official said. (Boston) (3/6) Email this Story
  • Mobile oncology application from ONCOassist gets CE mark
    ONCOassist has received the CE mark in Europe for a smartphone application designed to give oncologists mobile access to point-of-care clinical decision support tools. The ONCOassist app was designed for the iPad and iPhone, but the Irish company plans to have the technology available for Android devices in six to 12 months. Silicon Republic (Ireland) (3/6) Email this Story
  FDLI Items 
  • Don't Miss FDLI's Introduction to Medical Device Law and Regulation -- April 3-4
    At 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. Whether you are a new professional in the medical device industry or seasoned regulatory affairs professional needing a refresher, you will benefit from this course. Register today. Email this Story
  • Discover the Legal Framework for Drug Regulation -- April 3-4
    At Introduction to Drug Law and Regulation, speakers will review the laws and Food and Drug Administration regulations affecting the drug industry, establishing a foundation to help you and your organization get products approved and navigate regulatory problems. Experts will address the essential elements of FDA drug regulation in a systematic and comprehensive way. From the definition of "drug" to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, speakers walk you through key regulations and policies and will help you determine how those regulations and policies are applied. Register now. Email this Story
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Position TitleCompany NameLocation
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
Project Manager, Drug Safety and InnovationThe Pew Charitable TrustsWashington, DC
Associate Director, Regulatory Affairs CelgeneGreater New York City Area, NY
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
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The saddest aspect of life right now is that science gathers knowledge faster than society gathers wisdom."
--Isaac Asimov,
Russian-born American author and biochemist

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