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November 26, 2012News for the food and drug law community

  Drugs & Biologics 
  • FDA finds bacteria, fungi in 2 other NECC steroids
    The FDA added to its list of contaminated medicines after discovering fungal growth and bacteria in New England Compounding Center's steroids betamethasone and triamcinolone, which have not been tied to the recent meningitis outbreak. The CDC is not aware "of infections among patients that can be definitively linked to exposure to these drugs," CDC spokesman Curtis Allen said. The Tennessean (Nashville) (tiered subscription model) (11/22) Email this Story
  • Actelion seeks European approval for PAH drug macitentan
    Actelion Pharmaceuticals submitted an application to the European Medicines Agency seeking approval to market Opsumit, or macitentan, to treat pulmonary arterial hypertension. The company is positioning macitentan to be the successor of its blockbuster PAH drug Tracleer, which will lose its patent protection in 2015. Reuters (11/22) Email this Story
  • Mass. allows drug-sharing among hospitals facing shortages
    The Massachusetts Department of Public Health adopted emergency rules that will let hospitals share treatments to address drug shortages caused by the closure of the New England Compounding Center and its sister company Ameridose following a national meningitis outbreak. Although the change won't address long-term problems, it is "a significant and positive step toward easing the medication shortage," the Massachusetts Hospital Association said. The Boston Globe/White Coat Notes blog (tiered subscription model) (11/21) Email this Story
  Global Focus 
  • Pakistan creates regulatory body for medical devices
    The Pakistani government has signed into law legislation that will establish the Drug Regulatory Authority of Pakistan, which will regulate medical devices and pharmaceutical products in the country. All entities that oversee the medical device and pharmaceutical industries currently, such as the Federal Drugs Control Administration, will also become part of the new body. (Boston) (11/23) Email this Story
  Food & Dietary Supplements 
  • Failure to register may lead to U.S. ban on food companies
    Indian food and dietary supplements could be banned in the U.S. if food companies don't renew their FDA registration before 2013. "The U.S. administration, over-cautious about probable acts of terrorism, has made it mandatory for all facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA," according to an official with India's Agricultural and Processed Food Products Export Development Authority. The Economic Times (India) (11/23) Email this Story
  Medical Devices 
  • Custom device proposed rules now in comment phase
    The FDA is requesting public comment on the proposed criteria for its custom medical device exemption system after some revisions were made via the FDA Safety & Innovation Act. The notice calls for "information on and examples of appropriate uses" of the system, particularly from patients, manufacturers, doctors and dentists. (Boston) (11/23) Email this Story
  • Who should regulate makers of bed rails?
    The FDA and the Consumer Product Safety Commission are aware of deaths and patient safety problems with bed rails, and concerns have been raised about which agency should act and how problems should be addressed, according to this article. Potential resistance from Congress was a factor in a decision not to push for mandatory rules, said former medical device office director Larry Kessler. The New York Times (tiered subscription model) (11/25) Email this Story
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  FDLI Items 
  • FDLI Annual Conference Call for Sessions: Submit a Proposal by Dec. 7
    FDLI will host its 56th Annual Conference on April 23-24 in Washington, D.C. This event, attended by a large and diverse cross-section of food and drug law professionals, has risen to prominence throughout almost six decades because of the contributions from the food and drug law community. We invite you to submit a proposal for a general or breakout session. Submit your proposal online no later than Dec. 7. Proposal submission does not guarantee selection. Email this Story
  • Own the definitive guide on food and drug law
    Food and Drug Law and Regulation is one of the most comprehensive guidebooks ever published covering an area that accounts for more than 25% of all consumer spending in the United States. Equally relevant to practicing food and drug attorneys; in-house drug, device, biologics, cosmetics, food and tobacco counsel; consultants; law professors and students, this unique, 27-chapter resource includes more than a dozen chapters on FDA's vast and complex regulatory systems and standards. Preview the book. Order now. Email this Story

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American author and aviator

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