Drug Safety
More Information on Drug Safety
- Keynote Address by Sidney Wolfe, MD at “Selling Sickness” Conference, February 21, 2013
- Petition to the FDA for Black Box Warnings on ACE Inhibitors, ARBs, and Aliskiren, October 4, 2012
- Letter to FDA Addressing Recent Failures to Disclose New Drug Application Approval Packages in Timely Manner, July 23, 2012
- Letter on the Ability of Drug Companies to Add Safety Warnings to Their Products’ Labels, March 17, 2008
- Congressional Testimony on FDA Deficiencies, February 27, 2008
- Regulatory Affairs Journal Article: The U.S. FDA at a Crossroads, July 2006
- Statement on the 100th Anniversary of the FDA, June 27, 2006
- Testimony on Developing Cancer Biomarkers: A Case Study Involving ACF/Orlistat (Xenical), June 15, 2006
- Comments on Good Manufacturing Practices for Phase I Clinical Trial Drugs, April 3, 2006
- Testimony on the U.S. Drug Safety System, January 19, 2006
- Letter Detailing Needed Improvements to FDA’s MedWatch Adverse Events Reporting System, February 25, 2005
- Letter in BMJ on the New Zealand Ministry of Health Decision to Stop Funding Medsafe Program, August 23, 2004
- Article in JGIM: Remedies Needed in Reporting Adverse Reactions and FDA Use of Reports, January 31, 2003
- Op-Ed in Pharmacoepidemiology and Drug Safety on Drug Safety Withdrawals, December 2002
- Letter Urging FDA to Review Safety and Efficacy of All Pharmaceuticals Marketed Prior to 1938, May 29, 1996