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November 12, 2012News for the food and drug law community

  Drugs & Biologics 
  • FDA denies petition to withdraw high-dose Alzheimer's drug Aricept
    The FDA turned down Public Citizen's petition to pull the 23-milligram dose of Pfizer and Eisai's Alzheimer's treatment Aricept, or donepezil, from the market due to safety concerns. "Donepezil is 1 of only 2 drugs indicated for treating the severe stage of [Alzheimer's], and the 23 mg dose is shown to produce added cognitive benefits over the 10 mg strength," Dr. Janet Woodcock, the FDA's Center for Drug Evaluation and Research director, wrote in a response to Public Citizen. Medscape (free registration) (11/9) Email this Story
  • Healthy economic policies can ensure supply of lifesaving drugs
    The availability of lifesaving drugs can be guaranteed by immediately addressing the "well-intentioned but ill-advised" policy changes in the Medicare Modernization Act, according to this article by Rep. Bill Cassidy, R-La., a physician, and oncologist Patrick W. Cobb. It is time to make healthy economic policies that guarantee the continuous production of sterile injectables whose patents expire soon. Amending the reimbursement system is necessary to avoid future shortages and stabilize the market, they write. The Wall Street Journal (11/11) 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 
  • Ban on generic OxyContin sought by Canadian health ministers
    Some provincial health ministers are requesting that the federal government block generic versions of the narcotic painkiller OxyContin when its patent expires. It would be a "tragedy" to approve generic version of the drug as it would cause more death and addiction, Ontario Health Minister Deb Matthews said. "I am absolutely convinced that the devastation that would be caused ... would far, far outweigh any benefits," Matthews said. National Post (Canada) (11/11) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • Global Harmonization Task Force to formally end Dec. 31
    The Global Harmonization Task Force will officially cease operations Dec. 31. The task force, established in 1992 to harmonize regional and national medical device regulatory programs, has been replaced with a regulators-only entity, the International Medical Device Regulators Forum, which will carry on some of the GHTF's activities. Clinica (subscription required) (11/9) Email this Story
  • Plasma preparation device from Cytomedix wins FDA nod
    Cytomedix has obtained 510(k) clearance from the FDA to market the Angel platelet rich plasma technology, which is used to process small blood samples or mixtures of bone marrow aspirate and blood. The system is designed to allow the quick and safe preparation of concentrated plasma in clinical and point-of-care intraoperative environments. (11/8) Email this Story
  • Medtronic gets wider FDA OK for thoracic aorta lesions device
    Medtronic has received expanded premarket approval from the FDA for its Valiant stent graft to be used for treating all descending thoracic aorta lesions, except dissections. Previously, the device, delivered using the Captivia system, was approved only for fusiform aneurysms and saccular aneurysms/penetrating ulcers of the DTA in certain patients. (Boston) (11/9) Email this Story
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  • Become an author, write for FDLI's Food and Drug Law Journal
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