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

  Drugs & Biologics 
  Global Focus 
  • Chamber rates India, Canada low for drug patent protections
    The U.S. Chamber of Commerce ranked India as one of the worst in protecting patents and other intellectual property in a new index unveiled Tuesday. India's licensing policies favor domestic makers of generic drugs. Canada was also rated as having poor pharmaceutical patent protections. Brazil, Russia and China joined India at the bottom for overall protections of intellectual property. Reuters (12/11) Email this Story
  Food & Dietary Supplements 
  • FDA needs to know how antibiotics are used in livestock
    Thousands of people urged FDA Commissioner Dr. Margaret Hamburg to ask the pharmaceutical industry for critical information regarding drugs sold for use in agricultural animals, Dr. David Wallinga writes. This information is needed in the fight to stop the unnecessary use of tetracyclines, penicillins and other antibiotics to make chickens and pigs grow quicker on less feed, he writes. The Huffington Post (12/11) Email this Story
  Medical Devices 
  • Senators urge device tax implementation delay amid repeal efforts
    A group of senators asked Senate Majority Leader Harry Reid, D-Nev., to defer enforcement of the 2.3% medical device tax, as efforts to repeal the levy continue. In a letter, the group urged Reid to support efforts to make sure the U.S. "maintains its global leadership position in the medical technology industry and keeps good jobs here at home." (Boston) (12/10) Email this Story
  • EU regulators approve urology device from Mauna Kea
    Mauna Kea Technologies has earned CE mark approval in Europe to market Cellvizio UroFlex, which the company says is the first optical biopsy probe intended for urology uses. The device employs the firm's Cellvizio microscopy system, the use of which thus far has been limited to lung and gastrointestinal biopsies, to aid clinicians in diagnosing and monitoring bladder cancer. (12/7) Email this Story
  • OMB allows FDA to enable public to report tobacco law breaches
    The Federal Office of Management and Budget has granted a request by the FDA to enable the public to inform the agency about possible breaches in the Family Smoking Prevention and Tobacco Control Act through the use of a "Potential Tobacco Product Violations Report" form. The form lists several violations such as sales of flavored cigarettes and sales to minors. The form can be submitted via a smartphone application or e-mail. CSP (12/11) Email this Story
  FDLI Items 
  • Conference announcement and call for abstracts: FDA in the 21st Century
    The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is pleased to announce plans for this year's annual conference: The Food and Drug Administration in the 21st Century. This one-and-a-half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Mass. Registration information will be available on our website in the coming months. If you are interested in participating in the conference as a presenter, please send an abstract of the paper you would plan to present to by Friday. Conference papers need not be law review style or length. For additional information, please see the full announcement/call for proposals. Email this Story
  • Just released -- Pharmaceutical and Medical Device Compliance Manual, First Edition
    The fight against fraud and abuse in healthcare programs, and the pharmaceutical and medical device industries in particular, continue to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in healthcare, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies do that. Email this Story

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It is well for people who think to change their minds occasionally in order to keep them clean."
--Luther Burbank,
American botanist and horticulturist

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