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FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility
Inspection Found Sandoz Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills (Posted by Tom Lamb at DrugInjuryWatch.com) There is yet another apparent quality-control problem…
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August 2008: FDA Issues Its Final Version Of A New Rule Which May Give Complete Immunity To Drug And Medical Device Companies
FDA Rule Could Serve To Defeat Lawsuits Alleging Failure To Warn About Potentially Harmful Effects Of Prescription Drugs And Medical Devices (Posted by Tom Lamb at DrugInjuryWatch.com) Back in February 2008, in a post titled,…
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Wyeth v. Levine Supreme Court Hearing On Federal Preemption Of Drug Injury Lawsuits
Various Parties Have Filed Briefs With Their Arguments About Whether Or Not An Injured Patient Should Be Able To File A Lawsuit Against The Drug Company (Posted by Tom Lamb at DrugInjuryWatch.com) ********** UPDATE: Drug Injury Lawsuits Are Not Preempted By…
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August 2008: Byetta Associated With Hemorrhagic Pancreatitis And Necrotizing Pancreatitis
FDA Has Learned Of Six Such Cases Since October 2007 "Dear Doctor" Letter About Acute Pancreatitis In Patients Taking Byetta (Posted by Tom Lamb at DrugInjuryWatch.com) On August 18, 2008 the FDA issued a…
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Senators Kennedy And Leahy Introduce Legislation To Protect Patients From Dangerous And Defective Devices
August 2008 Senate Counterpart of HR 6381, Medical Device Safety Act 2008, Which Was Sponsored By Congressmen Waxman And Pallone (Posted by Tom Lamb at DrugInjuryWatch.com) In a June 27, 2008 article, "Newly Introduced…
