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March 6, 2013News for the food and drug law community

  Drugs & Biologics 
  • White House to Congress: Exempt FDA user fees from sequester
    The Obama administration urged Congress to allow the FDA to spend $41 billion in drugmaker user fees. The sequestration law limits the amount of fee-derived funds that the agency can spend, and experts warn that the agency will not be able to approve new drug and device applications quickly if the funds are subject to sequestration. Sequestration will slow progress toward cures and cost thousands of researchers their jobs, the White House warned. PharmaTimes (U.K.) (3/5), The Philadelphia Inquirer (2/28) Email this Story
  • Court upholds fraud conviction of ex-drug company official
    A panel of the 9th U.S. Circuit Court of Appeals upheld the fraud conviction of Scott Harkonen, former CEO of InterMune, for distributing misleading information about the clinical trial of Actimmune, a drug he publicized as a lung disease treatment. Three judges rejected the free speech arguments of Harkonen, saying fraudulent speech is not protected by the First Amendment. Bloomberg Businessweek (3/5) Email this Story
  • Par agrees to settle lawsuit tied to Megace for $45M
    Par Pharmaceutical pleaded guilty to improperly promoting the AIDS appetite drug Megace ES for uses unapproved by the FDA. The generics-maker agreed to settle a federal criminal probe and related civil lawsuit for $45 million. Par intentionally promoted Megace as a treatment for elderly residents of nursing homes who were losing weight, as well as other off-label uses, federal prosecutors said. Reuters (3/5) Email this Story
  Global Focus 
  • Germany approves Silence's cancer drug studies
    Germany's Federal Institute for Drugs and Medical Devices granted Silence Therapeutics approval for trials of its pancreatic cancer treatment ATU027 in combination with the anti-tumor medicine gemcitabine. The German regulator endorsed the studies as a combination treatment for various cancers, Silence said. Reuters (3/5) Email this Story
  • EU approves Bolton Medical's abdominal stent graft
    Bolton Medical has earned the CE mark in Europe for its Treovance system, which is used to treat abdominal aortic aneurysms with up to 10 millimeters of proximal neck length or up to 75 degrees of infrarenal neck angle. The stent graft is designed to support multiple configurations that match individual patient anatomies. (3/4) Email this Story
  Food & Dietary Supplements 
  • Kraft, Nestle, Ikea violate food quality standards in China
    Incoming products from food manufacturers Kraft, Nestle and Ikea were disposed of by Chinese authorities at the end of last year for violating China's food quality standards. A report from ABC News confirmed the detection of high levels of coliform bacteria in Ikea chocolate almond cakes and sorbitol in Nestle chocolate bars. Cream cheese from Kraft was disposed of after its expiration date passed before it was certified. (3/6) Email this Story
  Medical Devices 
  • House Republicans ask FDA to clarify proposed mHealth regulations
    House Energy and Commerce Committee Chairman Fred Upton, R-Mich., and other Republican House members have asked FDA Commissioner Dr. Margaret Hamburg via a letter sent on March 1 to provide clarity on the agency's proposal to regulate certain mobile health applications. The legislators expressed concern that manufacturers of mHealth apps, smartphones and tablets could be subjected to the 2.3% tax under the health care law if the FDA decides to regulate them as medical devices. (3/6) Email this Story
  FDLI Items 
  • Don’t miss the Controlled Substances Regulation event -- March 28 in Washington, D.C.
    Back by popular demand, this one-day advanced-level program will focus on significant developments in the FDA’s and DEA’s regulation of controlled substances. Government, industry and public interest experts will provide updates on the latest regulations and legislation affecting controlled substances stakeholders. Participants will discuss key developments after passage of the Food and Drug Administration Safety and Innovation Act (FDASIA); opioid Risk Evaluation and Mitigation Strategies requirements; and important scheduling and re-scheduling situations. Panelists will engage attendees in interactive dialogue on current hot topics and ongoing legal and policy decisions. Confirmed FDA speakers: Michael Klein, Ph.D., director, controlled substances staff, CDER, FDA; and Douglas C. Throckmorton, M.D., deputy director for regulatory programs, CDER, FDA. Get more about the program. Email this Story
  • Purchase now and get instant access -- Primers on the drug/biologics, medical device and cosmetics review process
    These 80-120 page, practical, user-friendly Primers are instantly available to you in PDF. These reports are extensively researched, referenced and edited by some of the most experienced and respected professionals in the field. And, just like our flagship publication the Food and Drug Law Journal (which has been published for more than six decades), you can rely on FDLI's reputation for fair, unbiased analysis and extensive, valuable sourcing and citation. Email this Story
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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 world is much more interesting than any one discipline."
--Edward Tufte,
American statistician and professor

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