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November 13, 2012News for the food and drug law community

  Drugs & Biologics 
  • Merck's bid for OTC Oxytron fails to win FDA panel backing
    The FDA's Nonprescription Drugs Advisory Committee voted not to recommend making Merck's transdermal patch Oxytrol, or oxybutynin, available over the counter for women with overactive bladder. Some panelists were concerned that women would use the patch who had another condition that needed a physician's treatment. The off-label use of the product by men was also a cause for concern. MedPage Today (free registration) (11/9) Email this Story
  • Report: NECC didn't qualify as drugmaker in 2003
    Massachusetts state officials and the FDA told the New England Compounding Center in 2003 that its drug compounding activities didn't constitute a manufacturing operation that would merit strict federal safety standards, according to a House Energy and Commerce Committee report. Despite evidence of health problems tied to the pharmacy's two drugs in 2002, government health regulators decided to leave oversight of the NECC to a state pharmacy board, the report said. Reuters (11/12) Email this Story
  • Calif. lawmaker eyes mandatory reporting of prescription drug deaths
    In response to a Los Angeles Times report on the failure of authorities to recognize how often people overdose on drugs prescribed by their doctors, California Sen. Curren D. Price Jr., D-Los Angeles, plans to push for a requirement that coroners tell the Medical Board of California about all prescription drug deaths. "There appears to be a disconnect between coroners and the medical board," Price said. "Hopefully, legislation will tighten that up and provide the kind of accountability we all expect." Los Angeles Times (tiered subscription model) (11/12) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • 64% of medtech firms unhappy with 510(k) process, survey finds
    A survey of 128 medtech firms finds 64% are dissatisfied with the FDA's 510(k) clearance process, largely because of communication delays and perceived inadequate scientific expertise at the agency. Those focused on ophthalmic, ENT and neurological devices expressed the highest discontent, according to the survey sponsored by the MedTech Resource Alliance. MedCityNews.com (11/12) Email this Story
  Tobacco 
  • Global agreement targets smuggling of tobacco
    Global health officials reached an agreement against tobacco smuggling, which weakens efforts to curb smoking and costs governments over $40 billion in revenue yearly. The deal, reached at the World Health Organization's 176-nation Framework Convention on Tobacco Control in Seoul, South Korea, includes the marking of tobacco packaging in order to monitor products and making it mandatory for member governments to license tobacco makers. Reuters (11/12) Email this Story
  FDLI Items 
  • Get first-hand knowledge from the first U.S.-based veterinary stem cell company
      
    Hear from Dr. Bob Harman, founder and CEO of Vet-Stem, the first U.S.-based commercial veterinary stem cell company, at FDLI's Regenerative Medicine: Key Developments in Regulation & Commercialization conference on Nov. 29 in Washington, D.C., and San Francisco. Dr. Harman is the CEO and principal clinical development director of the programs at Vet-Stem. Previously, he was the CEO of HTI-Bio-Services, a preclinical research company for veterinary and human pharmaceutical development. He has authored more than 500 contract study reports for animal health companies throughout the world and for submission to the FDA and USDA in support of the development of new animal and human health products. Don't miss the opportunity to hear Dr. Harman discuss the business of regenerative medicine. Email this Story

  • New primer: Medical Device Review Process: A Focus on Pre-Market Requirements
     
    This brand new primer walks readers through the process of determining whether a product qualifies as a medical device, describes the various FDA premarket requirements, and details the numerous pathways for bringing a medical device to market, including 510(k) applications, Premarket Approval Applications (PMAs), Investigational Device Exemptions, Humanitarian Device Exemptions and Custom Devices. Get instant access and download now. Email this Story
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Regulatory Counsel, GlobalConfidentialNorthern, NJ
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  SmartQuote 
The one permanent emotion of the inferior man is fear -- fear of the unknown, the complex, the inexplicable. What he wants above everything else is safety."
--H.L. Mencken,
American journalist and essayist


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