Category: FDA Drug Safety Oversight
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More Serious Side Effect Warnings And Recalls Predicted Due To Current FDA Approval System
August 2008 ASA Meeting: Sociologist Donald Light Presents His Paper, "Institutional Foundations of the Vioxx Disaster" (Posted by Tom Lamb at DrugInjuryWatch.com) On August 3, 2008, at the American Sociological Association (ASA) annual meeting…
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August 2008 Actavis Recall Of All Drugs Manufactured At Its Little Falls, NJ Plant
FDA Inspection “revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices” (Posted by Tom Lamb at DrugInjuryWatch.com) All of a sudden it seems that the sky is falling…
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Serious Problems With Generic Drug Makers In U.S. Continue To Be Discovered
The Safety Spotlight Has Been On Big Pharma In Recent Years; What Have These Lesser Known Manufacturers Been Getting Away With? (Posted by Tom Lamb at DrugInjuryWatch.com) A little more than two weeks ago…
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EU Drug Watchdog Wants Avelox Use Limited Mainly Due To Liver Toxicity Concerns
Risk Of Adverse Hepatic Reactions, Including Fatal Liver Injury, Is Cited by European Regulators At July 2008 Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The Committee for Medicinal Products for Human Use (CHMP), a…
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The FDA Is Not Ready For Federal Preemption Of Lawsuits Involving Drugs And Medical Devices
Something Old And Something New: Two Items From July 3, 2008 NEJM Show Why Preemption Applied In These Types Of Cases Is Bad Public Policy (Posted by Tom Lamb at DrugInjuryWatch.com) We start with…
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FDA Needs To Assure Us That There Is Quality Control For Generic Medications Sold In U.S.
In Wake of “Double-Dose” Digitek Pills And ETHEX Morphine Tablets Being Recalled, Drugmaker Ranbaxy Faces Allegations About Fake Data As Regards Quality Of Its Generic Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) A July 15,…
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Will There Be An Avelox – Liver Toxicity Warning Letter From Bayer Coming Soon In The U.S., Or Not?
In July 2008 FDA Said Avelox, With Other Antibiotics In Fluoroquinolone Class, Would Add A “Black-Box” Warning For Tendinitis And Tendon Ruptures (Posted by Tom Lamb at DrugInjuryWatch.com) On July 8, 2008 the FDA…
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Newly Introduced Legislation Would Protect Legal Rights of Patients Harmed By Defective Medical Devices
Bills Sponsored By Waxman And Pallone In The House As Well As Kennedy And Leahy In The Senate Would Right The Wrong Of Riegel Decision By U.S. Supreme Court (Posted by Tom Lamb at…
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Mylan’s Corporate Motto, Actavis On The Meaning Of GMP, And Who Is Ultimately Responsible For The Digitek Fiasco
FDA Statement Suggests Actavis Will Be Held Accountable For The Defective Digitek Pills, And Mylan Maintains That This Is Not My(lan) Problem (Posted by Tom Lamb at DrugInjuryWatch.com) When considering where things stand with the…
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FDA Staff Wants Amgen To Add Stronger Warning About Enbrel Side Effects In Children
June 2008 Staff Report Cites Cancers, Infections, And Neurological Problems Similar To Serious Side Effects In Adults (Posted by Tom Lamb at DrugInjuryWatch.com) On June 16, 2008 the FDA released a staff report, "Enbrel…