Tag: FDA
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FDA Transparency Task Force Will Hold Its Second Public Meeting On November 3, 2009
Emerging Safety Issues Concerning FDA-Regulated Products Is One Issue For Discussion Listed in October 2009 Federal Register Notice (Posted by Tom Lamb at DrugInjuryWatch.com) In the Federal Register for October 5, 2009 the FDA…
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FDA Wants Merck To Change Januvia Label With Increased Warning About Pancreatitis Risk
Is Januvia Similar To Byetta In Terms Of The So-Called Class Effect And Drug Injury Lawsuits Being Filed? (Posted by Tom Lamb at DrugInjuryWatch.com) On September 25, 2009 the FDA posted on its web…
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Asthma Drug Xolair Is Being Investigated By FDA For Possible Cardiac Problems
Serious Side Effects Include Heart Attacks, Abnormal Heart Rhythms, Heart Failure, And Various Conditions Caused By Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Xolair Is Associated With Higher Than Expected Reporting…
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Some Of The Drospirenone (DRSP) Progestin Used In Yaz And Yasmin Pills May Have Been Of Bad Quality
August 2009 FDA Warning Letter Sent To Bayer Relates To Quality Control Problems Found In March 2009 At German Facility Where DRSP Was Made (Posted by Tom Lamb at DrugInjuryWatch.com) By means of a…
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Public Surveys Indicate The Need For Reform In Drug Safety By Big Pharma And The FDA
Healthcare Providers And Patients Are Encouraged To Report Adverse Events Involving Approved Or Unapproved Indications As Well As Medication Errors (Posted by Tom Lamb at DrugInjuryWatch.com) In October 2006 Quintiles Inc., a leading CRO…
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FDA Conducts A Self-Critical Analysis Of Its Early Communications (ECs) Program
There Was Apparently A Brief Discussion About Effect Of ECs At July 2009 Agency's Drug Safety Oversight Board Meeting The Public Summary for the July 16, 2009 meeting of the FDA's Drug Safety Oversight…
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Some Users Of Alli And Xenical Have Developed Serious Liver Injury Including Liver Failure
FDA Early Communication Makes Clear That No Definite Association Between Liver Injury And Orlistat Has Been Established At This Time (Posted by Tom Lamb at DrugInjuryWatch.com) On May 22, 2009 we first reported that…
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Some Criteria To Determine A New Drug’s Potential For Causing Severe Drug-Induced Liver Injury (DILI)
In July 2009 FDA Issues Updated Guidance For Industry Document Concerning DILI In Premarketing Clinical Evaluation (Posted by Tom Lamb at DrugInjuryWatch.com) In July 2009 the FDA issued a Guidance for Industry document intended for pharmaceutical…
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Sandoz Metoprolol Succinate ER Tablets Recall Has Been Done Rather Quietly
Many Patients Are Dissatisfied With Lack Of Information From Sandoz, FDA, Or Their Pharmacy About Why This Generic Toprol Pill Was Pulled (Posted by Tom Lamb at DrugInjuryWatch.com) In an August 26, 2008 Drug…
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FDA And DOJ File Court Papers In November 2008 To Shut Down Actavis Totowa LLC
Federal Government Seeks A Permanent Injunction Against This Drug Company That Produced Defective Digitek Pills (Posted by Tom Lamb at DrugInjuryWatch.com) A November 13, 2008 Bloomberg article, "Actavis Sued by U.S. Regulators to Shut…