Category: FDA Drug Safety Oversight
-
Gardasil Vaccine Associated With 28 Deaths In 2008 According To Judicial Watch Report
This Public Interest Group Reviewed Gardasil Cases Found In FDA’s Vaccine Adverse Event Reporting System (VAERS) (Posted by Tom Lamb at DrugInjuryWatch.com) According to the Gardasil web site: GARDASIL is the only cervical cancer…
-
Can New FDA Transparency Task Force Acheive Its Lofty Objectives?
While Need For Greater Disclosure By FDA Is Evident, Drug Maker Trade Secrets May Be Difficult Obstacle To Overcome (Posted by Tom Lamb at DrugInjuryWatch.com) In early June 2009 it was announced that the…
-
April 2009 FDA “Patient Safety News” Videos For Doctors Online
Covers Bowel Cleansing Agents Visicol and OsmoPrep, As Well As Methadone Overdoses, Ethex Generic Drug Recall, And Medication Errors (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA's Patient Safety News (PSN) is a series of…
-
FDA Presents Ten Years Of Summary Statistics For Its Adverse Event Reporting System (AERS)
Information Current As Of December 31, 2008; FDA Says It Will Provide Quarterly Updates For This AERS Data (Posted by Tom Lamb at DrugInjuryWatch.com) In early April 2009 the FDA released its Adverse Event…
-
Marcia Angell’s List Of Seven Things That Should Be Done By The New FDA Leadership
Dr. Angell, Former NEJM Editor-In-Chief And Current Harvard Medical School Professor, Writes An April 2009 Editorial For The Boston Globe (Posted by Tom Lamb at DrugInjuryWatch.com) Marcia Angell was the first woman to serve…
-
FDA Staffers Tell Obama There Is Frustration And Outrage Over Misdeeds Of Former Agency Officials
In April 2, 2009 Letter They State There Is "systemic corruption and wrongdoing that permeates all levels of FDA" Which Needs To End (Posted by Tom Lamb at DrugInjuryWatch.com) ABC News has posted on…
-
FDA’s “Sentinel Initiative” Project For Monitoring Medical Product Safety: March 2009 Update
Agency Publishes Notice In March 9 Edition Of The Federal Register: Seeking Public Comment On Proposed Voluntary Survey (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2008 the FDA published a white paper, "The…
-
FDA Warns About Rare Brain Infection PML Linked To Psoriasis Drug Raptiva
European Union Regulators, On Same Day, Recommend That Raptiva Be Withdrawn Because Its Risks Outweigh The Benefits ******************** Update: April 2009: Raptiva Recall In U.S. On April 8, 2009 we learned that Raptiva has been recalled due…
-
2008 Emory Law Journal Article Presents Ketek As A Case Study In FDA Regulatory Failure
Discusses The Dire Consequences Of Fraudulent Science, Federal Preemption, And Corporate Deregulation (Posted by Tom Lamb at DrugInjuryWatch.com) Thomas O. McGarity, of the University of Texas School of Law, is uniquely positioned to give…
-
February 2009: FDA Releases Its Quarterly List Of Drugs With Possible Safety Problems
FDA List Is Based On Reports Made To Adverse Event Reporting System (AERS) Between July And September 2008 (Posted by Tom Lamb at DrugInjuryWatch.com) On February 4, 2008 the FDA posted on its web…