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Industry News: Page 279
Pharmaceuticals
FDA, FTC Issue Joint Warning Letter to Web Site Offering Fraudulent H1N1 Flu Supplements*
Agencies continue effort to protect public health from illegal Web activity.
November 2, 2009
Pharmaceuticals
FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use*
The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years.
November 2, 2009
Pharmaceuticals
ISPE Hosts Global Pharma Regulators for Education in France*
Pharmaceutical science and manufacturing industry professionals from around the world gathered in Strasbourg, France to share expertise and gain insight to "Managing Knowledge through Science and Risk Assessment" at the ISPE 2009 Strasbourg Conference.
November 2, 2009
Medical Device/Packaging
Medical Device Power Cords Safety Investigation: Initial Communication*
FDA is investigating whether certain types of power cords used with medical devices may be defective. Two medical device manufacturers (Hospira, Inc. and Abbott Nutrition) have sent FDA 122 reports of sparking, charring, and fires from the power cords used with their devices.
November 2, 2009
Regulatory
September 2009 Drug Safety Labeling Changes - 36 drugs with changes*
The "Summary Page" provides a listing of drug names and safety labeling sections revised.
November 2, 2009
Regulatory
The 'oldest profession' still follows the money
Packaging technologies serve as part of the 'tool kit' to identify pharmaceutical counterfeits.
November 2, 2009
Adherence/Delivery
Relenza (zanamivir) Inhalation Powder must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator*
GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation.
October 27, 2009
Adherence/Delivery
CT Brain Perfusion Scans Safety Investigation: Initial Notification*
FDA notified healthcare professionals that it has become aware of radiation overexposures during perfusion CT imaging performed to aid in the diagnosis of stroke at a particular facility, the patients receiving radiation doses that were approximately eight times the expected level.
October 27, 2009
Regulatory
Unomedical Manual Pulmonary Resuscitator - Recall*
Unomedical and FDA notified healthcare professionals about the recall of the single-patient use Manual Pulmonary Resuscitator because of a malfunction which may impair the ability of the device to generate the positive pressure necessary to function properly and could potentially cause serious adverse health consequences or death.
October 27, 2009
Regulatory
Transparent hologram seal
For pharmaceutical industry professionals, the Dec. 6-8 event in Amsterdam will provide track-and-trace instruction, with tours of serialized packaging site.
October 27, 2009
Regulatory
Desire to Benefit Patients Might Undercut Research Goals, New IRB Study Finds*
A doctor who is also an investigator on a clinical trial has a patient who could benefit from the trial, but does not quite fit the eligibility criteria.
October 25, 2009
Regulatory
WINMEC RFID Executive Forum - Modifying Global Business for Competitiveness*
RFID has started to have a major impact on various industry segments ranging from retail to healthcare, and, energy to manufacturing.
October 25, 2009
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