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

  Drugs & Biologics 
  • Mass. extends shutdown of Ameridose to Feb. 22
    The Massachusetts Department of Public Health extended the temporary closure of Ameridose, the drug company with the same owners as the specialty pharmacy tied to a national meningitis outbreak, as federal and state authorities continue to investigate the facility's sterility practices. "The company remains committed to working cooperatively with both the Mass Board of Pharmacy and the FDA and ... has agreed to extend its temporary closure ... through Feb. 22, while it continues its communications with the FDA," according to statement from Ameridose. The Boston Globe (tiered subscription model)/White Coat Notes blog (1/3) Email this Story
  • France scrutinizes risks of newer contraceptive pills
    French health regulators will stop reimbursing prescription costs of third-generation contraceptive pills starting March 31, after a woman sued a drugmaker over alleged side effects. The regulators are considering limits on the use of third- and fourth-generation contraceptive pills, which are said to have greater risks than predecessors. Regulators also are looking at doctors' prescription practices. Reuters (1/3) Email this Story
  • India to introduce drug pricing order by March
    The government of India is expected to unveil by March an order that will determine the retail prices of more than 640 drugs. The order will define the mechanism and rules for setting prices of treatments. The National Pharmaceutical Pricing Authority has denied requests by drugmakers for price increases pending the order. Business Standard (India) (1/3) Email this Story
  • Other News
  Food & Dietary Supplements 
  Medical Devices 
  • Abbott's heart stent gains FDA approval
    The FDA has granted Abbott Laboratories approval for its Xience Xpedition system, which the company said is targeted for immediate release in the U.S. The heart stent administers the drug everolimus to aid in the prevention of blood vessel reclogging. Reuters (1/3) Email this Story
  • FDA gives Alphatec nod on 2 spinal devices
    Alphatec Spine has gained 510(k) clearance from the FDA to market its Pegasus system, an anterior interbody device delivered to the cervical spine without the need for impaction. The agency also cleared the company's ILLICO FS Facet Fixation System, which aids surgeons in stabilizing spinal segments without using rods and screws. (1/3) Email this Story
  • Chinese legislators consider tobacco control law enactment
    Lawmakers in China see a need for a national tobacco control law, according to a standing committee's report. In March, 90 National People's Congress deputies have introduced three bills supporting the creation of a law to prevent the hazards associated with tobacco use. Four other proposals were made for legislation on smoke-free public places. China Daily (Beijing) (1/2) Email this Story
  FDLI Items 
  • Global Developments: What's Your GPS? Conference -- Food Week 2013, Feb. 8
    Participants in FDLI's Global Developments conference during Food Week 2013 will hear robust discussion of significant international developments affecting global food stakeholders, including the increasingly complex global food supply chain, expanding access to global markets and Food Safety Modernization Act mandates requiring foreign food facilities to register with FDA. Join us to learn about the critical issues that will affect your business and clients through country and regional case studies, including Brazil and China. Learn more about Food Week 2013. Email this Story

  • Food "Hot Topics" -- Feb. 5, During Food Week 2013 -- You can't afford to miss these discussions!
    What challenges are food companies, regulators, and attorneys facing as the political landscape shifts toward grassroots movements? How are social media platforms changing how the food industry markets products and monitors press coverage? Hear in-depth discussions of these topics, as well as generally-recognized as safe (GRAS) developments and food truck regulations, during the "Hot Topics" conference during Food Week 2013. Learn more about Food Week 2013. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

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

Genius is nothing but a great aptitude for patience."
--Georges-Louis Leclerc Comte de Buffon,
French naturalist, mathematician, cosmologist and encyclopedia author

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