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March 4, 2013News for the food and drug law community

  Drugs & Biologics 
 
  • FDA to scrutinize 30 compounders in 2 months
    The FDA plans to inspect around 30 drug compounders in the next two months as part of heightened efforts following a deadly meningitis outbreak tied to compounded drugs. The pharmacies mainly produce sterile drugs for health care providers across the country, FDA spokeswoman Erica Jefferson said. Bloomberg Businessweek (3/1) Email this Story
  • FDA staff: Calcitonin salmon may carry cancer risk
    A link between osteoporosis treatments containing calcitonin salmon and cancer risk is possible, according to briefing documents from FDA staff reviewers. The reviewers raised questions about the drugs' usefulness in preventing bone breaks due to osteoporosis in postmenopausal women, the reviewers said. An FDA panel is set to discuss the products on Tuesday. Reuters (3/1) Email this Story
  • British pharma asks for delay in pricing system
    A group of British drug wholesalers, concerned about supply chain issues, asked for a one-month grace period before the introduction of a new value-based pricing system. The new program will replace a 55-year-old system that allowed the industry to set its own prices -- under a cap -- and negotiate every five years. PharmaTimes (U.K.) (3/1) Email this Story
  • Europe supports push to cure rare conditions
    The European Commission will spend about $187 million on 26 research projects on rare diseases, involving research teams from 29 countries. The goal is to discover effective treatments for a metabolic, immune and cardiovascular disorders, among others. PharmaTimes (U.K.) (3/1) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • Mercator gains EU approval for micro-infusion catheters
    Mercator MedSystems has earned the CE mark to market its Cricket and Bullfrog micro-infusion catheters in Europe. The devices already have U.S. approval. The devices are used to deliver drugs straight to deep tissue through blood vessel walls, keeps the injected agent from spreading throughout the body while also allowing for a high concentration near the targeted area. MedGadget.com (3/1) Email this Story
  Tobacco 
  • CDC: 1 in 5 adult smokers have tried e-cigarettes
    The number of U.S. adult smokers who have tried electronic cigarettes rose from about 10% in 2010 to about 21% in 2011, according to a CDC study released on Thursday. Current smokers were more likely to use the devices than nonsmokers, researchers said. "There is still a lot we don't know about these products, including whether they will decrease or increase use of traditional cigarettes," CDC director Dr. Tom Frieden said. U.S. News & World Report/HealthDay News (2/28) Email this Story
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Top five news stories selected by FDLI SmartBrief readers in the past week.

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  FDLI Items 
  • 2013 conference calendar -- speak, register & save the dates!
    There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
    • Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
    • Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
    • FDLI Annual Conference | April 23-24 | Washington, D.C.
    • FDLI International Conference | June 6-7 | Beijing, China. New date!
    • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
    • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Location TBD
    • FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
    • Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
    Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
Position TitleCompany NameLocation
Associate Director, Regulatory Affairs CelgeneGreater New York City Area, NY
Project Manager, Drug Safety and InnovationThe Pew Charitable TrustsWashington, DC
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
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The person whose doors I enter with most pleasure, and quit with most regret, never did me the smallest favor."
--William Hazlitt,
British writer and philosopher


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