Archive for April, 2010

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  FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

  0April 29, 2010
  The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer...
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  FDA Approves New Device for Adults with Severe and Persistent Asthma

  0April 27, 2010
  The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and...
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  FDA Launches Initiative to Reduce Infusion Pump Risks

  0April 23, 2010
  The U.S. Food and Drug Administration today announced a new initiative to address safety problems associated with external infusion pumps,...
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  FDA Adds Boxed Warning To Propylthiouracil

  0April 21, 2010
  FDA has added a Boxed Warning to the label for propylthiouracil, to include information about reports of severe liver injury...
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  FDA Announces Draft Revised Guidance on Transparency and Advisory Committees

  0April 21, 2010
  The U.S. Food and Drug Administration today announced draft guidance that would expand transparency and disclosure when the agency grants...
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  FDA to Address Challenges of Using Complex Medical Devices in the Home

  0April 20, 2010
  Agency’s Home Use Initiative to provide guidance, other measures to help caregivers, patients The U.S. Food and Drug Administration today announced...
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  FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site

  0April 19, 2010
  Site contains new information on Center for Devices and Radiological Health decisions The U.S. Food and Drug Administration launched the Center...
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  CBI’s 3rd Annual Bio/Pharmaceutical Drug Safety Forum

  0April 17, 2010
  April 27-28, 2011 in Philadelphia, PA ~ The purpose of the REMS is to ensure the benefit of the drug outweighs...
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  Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available

  0April 13, 2010
  The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances...
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  FDA Approves Pancreatic Enzyme Product, Pancreaze

  0April 12, 2010
  The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the...