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Merck’s Kenneth Frazier and Congressman Waxman Differ Over “The Lessons of Vioxx”
Merck’s General Counsel Frazier Takes Issue With Congressman Henry Waxman’s June 2005 NEJM Article In the September 29, 2005 edition of The New England Journal of Medicine ("NEJM") is a letter to the editor…
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Paxil Label to Get an Increased Warning About Possible Birth Defects
Glaxo Says It Does Not Know Whether Paxil Causes Any Abnormality or Malformation in Babies A September 27, 2005 FDA MedWatch alert broadcast the news that GlaxoSmithKline Plc had sent a "Dear Doctor" letter…
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Biogen Idec and Elan Want to Resume Selling Their MS Drug Tysabri in the U.S.
Tysabri Recalled From the Market in Early 2005 Due to PML, a Fatal Brain Condition Biogen Idec Inc. and Elan Corp., the makers of the multiple sclerosis ("MS") drug Tysabri, filed papers with the…
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New Drug Industry Web Site Intended to Give Access to Findings From Clinical Trials
Doctors and Patients Can Search for Drug-safety Information Using IFPMA Clinical Trials Portal On September 21, 2005 the International Federation of Pharmaceutical Manufacturers and Associations ("IFPMA") established a new web site called the IFPMA…
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FDA Warning Letters About Misleading DTC Ads Tripled During Last Year
Most Common Offense is De-emphasizing Serious Side Effect Risks in Advertisements On September 19, 2005 Thomas Abrams, head of FDA’s Division of Drug Marketing and Communications, told food and drug regulatory lawyers attending a…
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Pfizer Agrees to New Celebrex Safety Guidelines in Canada
Health Canada Revisions to Celebrex Label Accepted by Pfizer Canada On September 21, 2005 Pfizer Canada announced the drug company had agreed to make changes suggested by Health Canada that add new safety guidelines…
