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January 9, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA flags fractures, cardiovascular risk tied to J&J's canagliflozin
    The FDA raised concerns about possible stroke and bone-related safety risks tied to Johnson & Johnson's proposed diabetes treatment canagliflozin, or Invokana. An analysis of cardiovascular events showed a numerical imbalance in strokes although it didn't show a greater risk in a combined measure of cardiovascular deaths, hospitalization, strokes and heart attacks, the FDA said. The drug will be reviewed by the FDA's endocrinologic and metabolic drugs advisory committee as part of the approval process. Fox Business/Dow Jones Newswires (1/8) Email this Story
  • FDA, state officials probe another Mass. compounding pharmacy
    The FDA joined Massachusetts officials in a surprise inspection of an unnamed pharmacy similar to the New England Compounding Center, which was tied to a national fungal meningitis outbreak. "The FDA has authority over certain things and if they feel this registrant is performing business practices in their domain, that's their call," said Dr. Madeleine Biondolillo, director of the state's Bureau of Health Care Safety and Quality. Cease-and-desist orders have been issued to at least four drug compounders since the start of the surprise inspections. The Boston Globe (tiered subscription model)/White Coat Notes blog (1/8) Email this Story
  • High court dismisses embryonic stem cell research funding challenge
    The Supreme Court rejected without comment a case challenging federal funding for embryonic stem cell research. The challenge, led by adult stem cell researchers James Sherley and Theresa Deisher, argued that research using human embryonic stem cells was in violation of a federal law banning the use of such embryos for scientific purposes. President Barack Obama reversed an earlier ban on federal funding for embryonic stem cell research, though the initial extraction of stem cells still depends on private funds because of the existing law. (1/7) Email this Story
  • Restaurants, PhRMA react to relaxed Mass. rules on dining with docs
    Restaurant owners welcomed last fall's revision to a Massachusetts law allowing drugmakers and medical-device makers to pay for "modest" meals at informational sessions. Marjorie Powell of the Pharmaceutical Research and Manufacturers of America said the rules create some uncertainty for drugmakers because the reporting requirements allow for additional information to be requested. Meanwhile, certain groups are worried that relaxing the meal ban puts corporate interests above the well-being of patients. The Boston Globe (tiered subscription model) (1/7) 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.
  Global Focus 
  • EU clears expanded use of Pfizer's Prevenar 13 vaccine
    The European Commission approved the use of Pfizer's pneumococcal conjugate vaccine, Prevenar 13, in children ages 6 to 17. The vaccine prevents diseases caused by the bacterium Streptococcus pneumoniae. Children belonging to this age group who haven't previously received the vaccine may get a single dose of Prevenar 13, Pfizer said. Reuters (1/8) Email this Story
  Food & Dietary Supplements 
  • Healthy snacks producer pulls products for milk use
    Somersault Snack and the FDA have initiated a recall of Somersault's cinnamon crunch products for the use of an undeclared ingredient. The company found that the flavoring ingredient in the affected products has milk. Recalled products, which were distributed across the country, have sell-by dates of Aug. 30 or earlier. Food Business Review (1/8) Email this Story
  Medical Devices 
  • Biophotonic device gets FDA OK for 6 medical conditions
    BioPhotas has secured FDA clearance to market its Celluma biophotonic device, which treats muscle, joint and skin conditions using three different light wavelengths. The device has been cleared for use in patients with compromised local blood flow, muscle spasms and four other conditions. (1/8) Email this Story
  • FDA includes more tobacco products in 2013 agenda
    The regulatory agenda of the FDA for 2013 has been released stating the agency's plan to introduce a proposed rule to direct additional tobacco products in accordance to the Family Smoking Prevention and Tobacco Control Act. The agency regulates cigarettes, smokeless tobacco and roll-your-own tobacco products, and it did not indicate which other products it intends to regulate. The agenda specifies that the agency has until April to release the proposal. CSP (1/8) Email this Story
  FDLI Items 
  • Volunteer to serve on an FDLI committee by Jan. 25
    FDLI committees comprise volunteers who advise FDLI staff and provide expertise for program and publication development. The Institute depends on the dedication of our committee volunteers to help drive our mission and create a stronger food and drug law community. Committees include Academic Programs, Audit, Austern Writing Awards, Drugs and Biologics, Editorial Advisory Board (Journal), Editorial Advisory Board (Primers/Monographs), Editorial Advisory Board (Policy Forum), Editorial Advisory Board (Update), Finance, Food and Dietary Supplements, Medical Devices and Tobacco. More details online. Typical service is a three-year term beginning at the Annual Conference (usually April). To be considered for committee service (April 2013-April 2016), please e-mail Michael Sprott at by Jan. 25. Committee appointments will be announced in March. Email this Story
  • Introduction to Food Law and Regulation -- Feb. 5-6 -- Washington, D.C.
    For a new professional in the field, understanding the numerous food law issues and requirements can be a daunting task. FDLI's industry standard course, Introduction to Food Law and Regulation, is a one-stop resource that provides the basics of food law and regulation. This comprehensive two-day program on the essential elements of food law and regulation, taking place during Food Week 2013, is valuable for new members of the legal community, government officials, advertising, marketing and investment professionals, and others new to the food and dietary supplement community. This conference is also an excellent refresher for the seasoned professional. 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
Senior Counsel – Medical Device/Combination ProductAmgenThousand Oaks, CA
Counsel, Advertising and PromotionsMylan Pharmaceuticals Inc.Basking Ridge, NJ
Regulatory ConsultantThe Weinberg GroupWashington, DC
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.

Memory is a complicated thing, a relative to truth, but not its twin."
--Barbara Kingsolver,
American novelist, essayist and poet

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