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Public Workshop
The Food and Drug Administration (FDA) in collaboration with the National Institutes of Health (NIH) are announcing a public workshop to facilitate medical device innovation in the development of the Artificial Pancreas (or Autonomous System) for the treatment of Diabetes Mellitus. An Artificial Pancreas is a medical device that links a glucose monitor to an…
Class I Medical Device Recall: Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as "All-Med Medical Products, Inc." and "Marquette Medical, Inc." Brands and Provided to Some Consignees in Bulk Without Labeling
Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A “coring” Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The defect in the port as a result of coring can cause the ports to leak. The core can…
FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [10-8-2010] The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of Meridia (sibutramine) because this drug may pose unnecessary cardiovascular risks to patients. FDA has requested that Abbott Laboratories—the manufacturer of Meridia—voluntarily withdraw this drug product from…
7345.848
Download PDF Version of Report  Back to Compliance Programs Main Page [email protected], or by mail to: Division of Inspections Surveillance, HFM-650Office of Compliance and Biologics QualityCenter for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Suite 200NRockville, MD 20852-1448 Domestic Post-Market Inspections: Inspections classified NAI and VAI: Notify CBER, Office of Compliance and…
New and Generic Drug Approvals
Visit Drugs@FDA to search Drug Approval Reports by Month. October 06, 2010 Aridol (mannitol) Inhalation Powder, Pharmaxis, Inc., Approval Eligard (leuprolide acetate) Injectable Suspension, sanofi-aventis, Labeling Revision October 05, 2010 Atomoxetine Hydrochloride Capsules, TEVA Pharmaceuticals, Approval Carbidopa, Levodopa and Entacapone Tablets, Sun Pharmaceutical, Tentative Approval COMBIVIR (lamivudine/zidovudine) Tablets, GlaxoSmithKline, Labeling Revision DURAMORPH (morphine sulfate) Injection,…
Guidance for Industry and FDA Staff
Document issued on: September 30, 2010 For questions regarding this document contact Robert Doyle at 301-796-5863 or via email at [email protected]. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological HealthOffice of Communications, Education, and Radiation ProgramsDivision of Mammography Quality and Radiation ProgramsElectronic Products Branch Contains Nonbinding Recommendations Preface Public…
Safe Use Initiative: Opportunities for Collaboration
A sampling of drugs, drug classes or therapeutic areas that could benefit from stakeholder collaboration  Long-acting beta agonists (LABA)Some patients who take long-acting beta agonists (LABAs) for asthma experience exacerbations of asthma symptoms, which can result in hospitalizations and death. On June 2, 2010, FDA announced revisions to the prescribing information for LABA labels…
FDA Patient Safety News for October 2010
FDA Patient Safety NewsA Video News Show for Health Professionals Show #103,Oct. 2010 Video Podcast(Instructions) RSS News Feed(Instructions)  Recalls and Safety Alerts Importance of Influenza Vaccination for Health Care Personnel (from November 2008) Preventing Cross-Contamination in Endoscope Processing (from February 2010)     Preventing Medical Errors Never Use Parenteral Syringes for Oral…
FDA Patient Safety News for August 2010
FDA Patient Safety NewsA Video News Show for Health Professionals Show #103,Oct. 2010 Video Podcast(Instructions) RSS News Feed(Instructions)  Recalls and Safety Alerts Importance of Influenza Vaccination for Health Care Personnel (from November 2008) Preventing Cross-Contamination in Endoscope Processing (from February 2010)     Preventing Medical Errors Never Use Parenteral Syringes for Oral…