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November 5, 2012News for the food and drug law community

  Drugs & Biologics 
  • Roche's Zelboraf and Bristol's Yervoy win NICE support
    The U.K. National Institute for Health and Clinical Excellence recommended Roche Holding's Zelboraf, or vemurafenib, and Bristol-Myers Squibb's Yervoy, or ipilimumab, for use by the National Health Service in the treatment of skin cancer. The agency initially decided not to endorse the drugs but reversed its decision after Roche and Bristol agreed to offer the drugs at a discounted price. Reuters (11/2), (India) (11/3) Email this Story
  • FDA: Decisions on some drugs pushed back by Sandy
    Superstorm Sandy postponed for as much as two days regulatory timelines for prescription drugs, biosimilar drugs and medical devices with target dates around Oct. 29 and 30, the FDA said. It is weighing whether a delay is needed for drugs with target dates on or after Oct. 31. Reuters (11/2) Email this Story
  • Markey unveils bill to bolster FDA oversight of drug compounders
    Rep. Ed Markey, D-Mass., introduced the Verifying Authority and Legality in Drug Compounding Act to authorize FDA oversight of compounding pharmacies. "Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory," Markey said. The bill "ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies." Blog (11/2) Email this Story
  • Mass. regulators and Ameridose extend closure to Nov. 19
    Ameridose, a sister company to the New England Compounding Center, agreed with Massachusetts regulators to extend its closure until Nov. 19 as federal and state investigators continue to inspect its facilities. In addition, state regulators approved emergency regulations to bolster the oversight of drug compounders. The NECC has been linked to an outbreak of meningitis due to contaminated injectable steroids. Reuters (11/2) Email this Story
  Global Focus 
  • Pioneering gene therapy gains approval in Europe
    The European Commission approved uniQure's Glybera, or alipogene tiparvovec, for the treatment of the exceedingly rare genetic disorder lipoprotein lipase deficiency. The approval makes Glybera the first gene therapy to be cleared in a Western market. UniQure is preparing to apply for regulatory approval in other markets, including the U.S. and Canada. BioWorld Online (free registration) (11/2), Reuters (11/2) Email this Story
  Food & Dietary Supplements 
  • FDA, state officials investigate Wegmans' spinach recall
    The FDA and state health officials are investigating Wegmans' recall of spinach, according to spinach distributor State Garden's lawyer Gina Ameci. "Our understanding is that Wegmans voluntarily recalled two sizes of organic spinach as a precaution yesterday," Ameci wrote in a statement. "Currently, State Garden is fully cooperating with all federal, state, and local authorities in connection with Wegmans' voluntary recall." (11/2) Email this Story
  Medical Devices 
  • Accuray scores FDA clearance for next-gen CyberKnife device
    The FDA has cleared Accuray to market the CyberKnife M6 Series, a next-generation line of the company's radiosurgery system. The company also secured 510(k) clearance for the InCise Multileaf Collimator, which is used to tailor an X-ray beam to the dimensions of a tumor, and is designed to work with the new FM and FIM CyberKnife models. (11/2) Email this Story
  • Cook County's finance committee OKs $1 cigarette tax increase
    The Cook County Board's Finance Committee approved the proposed $1-per-pack cigarette tax hike, increasing its chances of approval as part of a bigger budget package for next year. The increase, which could go into effect March 1, will raise the combined tax on a pack of cigarettes to $6.67 in Chicago. Chicago Sun-Times (11/2) Email this Story
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  • Learn to think like an experienced drug law professional -- Nov. 13-14 in N.J.
    At this program, speakers will review the laws and FDA regulations affecting the drug industry, and help you and your organization get products approved and navigate regulatory issues. Experts will review 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 will walk attendees through key regulations and policies. Register now. Email this Story

  • Become an author -- write for FDLI's Food and Drug Law Journal
    For more than 60 years, this award-winning journal has offered readers scholarly, in-depth, analytical articles, providing insight into the actions of FDA, FTC, and USDA, how the courts interpret these actions, and the reaction of industry. FDLI encourages authors to submit articles for review by the Journal’s Editorial Advisory Board, and pending a positive review, publication. The Journal publishes four times per year. The next deadline for article submission is Dec. 1. Please contact Jenny Kane ( to submit an article or with questions. Email this Story
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