Reporting of 6-Month vs 12-Month Data in a Clinical Trial of Celecoxib -
JB Hrachovec, M Mora, JM Wright, TL Perry, KL … - JAMA, 2001 - Am Med Assoc
... and Dr Simon is on the speakers bureau for Merck and is a ... 2. Witter J. Medical Officer
Review. Available at: http://www.fda.gov/ohrms/dockets/ac/01/briefing ...

Rosuvastatin safety: lessons from the FDA review and post-approval surveillance -
MH Davidson - eds, 2004 - Expert Opinion
... Rosuvastatin safety: lessons from the FDA review and post-approval surveillance ... A
press release from Merck in 1997 reported a 0.8% incidence of rhabdomyolysis ...

FDA Panel: Keep COX-2 Drugs on Market Black Box for COX-2 Labels, Caution Urged for All NSAIDs -
BM Kuehn - JAMA, 2005 - Am Med Assoc
... A review of the clinical trials on rofecoxib suggests naproxen ... the market in September
by its manufacturer, Merck & Co ... A. Gross, MD, chair of the FDA?s drug ...

[DOC] At FDA, Strong Drug Ties and Less Monitoring
G Harris - New York Times, 2004 - tricare.osd.mil
... Merck withdrew Vioxx in September after a test showed ... of Medicine, the government's
principal scientific review agency, to ... drugs, Dr. Graham of the FDA told a ...

Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy -
EH Turner, AM Matthews, E Linardatos, RA Tell, R … - New England Journal of Medicine, 2008 - content.nejm.org
... Failing the public health -- rofecoxib, Merck, and the FDA. ... selective reporting from
studies sponsored by pharmaceutical industry: review of studies in new ...

The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective. -
M Meadows - FDA Consumer, 2002 - questia.com
... is also continuous interaction throughout the review process ... over roughly six years,
the sponsor Merck Research Laboratories ... West Point, Pa., and the FDA had a ...

… benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee -
PF Boudes - Contemporary Clinical Trials, 2006 - Elsevier
... Introduction, a review of Clinical Pharmacology, a review of Efficacy, a review
of Safety ... The FDA usually follows the recommendation of its advisory panel [7 ...

FDA ponders future of NSAIDs: Pfizer reluctantly withdraws Bextra. -
D Young - American Journal of Health-System Pharmacy, 2005 - pt.wkhealth.com
... NSAIDs to conduct a comprehensive review and analysis ... the September 30, 2004, withdrawal
of Merck's rofecoxib, or ... Even though FDA's advisory panel voted 17-13 ...

Tailoring Arthritis Therapy in the Wake of the NSAID Crisis -
NJ Olsen - New England Journal of Medicine, 2005 - content.nejm.org
... and the authority to require review before dissemina ... use of non- steroidal
antiinflammatory drugs (NSAIDs): Merck ... market; a closely divided FDA advisory panel ...

The Lessons of Vioxx--Drug Safety and Sales -
HA Waxman - New England Journal of Medicine, 2005 - content.nejm.org
... and the authority to require review before dissemina ... use of non- steroidal
antiinflammatory drugs (NSAIDs): Merck ... market; a closely divided FDA advisory panel ...