FDA standards - Good enough for government work?

New England Journal of Medicine

Volumn 353, Issue 10, 2005, Pages 969-972

  Avorn, Jerry ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEXFENFLURAMINE; FENFLURAMINE; HYDRALAZINE PLUS ISOSORBIDE DINITRATE; HYPNOTIC AGENT; PARTIAL AGONIST; RAMELTEON; RIMONABANT; UNCLASSIFIED DRUG;

CLINICAL TRIAL; COGNITIVE DEFECT; CONGESTIVE HEART FAILURE; DROWSINESS; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG SAFETY; FALLING; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TOXICITY; GOVERNMENT; HUMAN; INSOMNIA; MEDICAL DOCUMENTATION; MEDICAL RESEARCH; NEUROTOXICITY; OBESITY; PRIORITY JOURNAL; PULMONARY HYPERTENSION; RACE DIFFERENCE; SHORT SURVEY; SIDE EFFECT; STANDARDIZATION; VALVULAR HEART DISEASE;

CANNABINOIDS; DEXFENFLURAMINE; DRUG APPROVAL; HUMANS; OBESITY; PIPERIDINES; PYRAZOLES; SLEEP INITIATION AND MAINTENANCE DISORDERS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 24344465285     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp058174     Document Type: Short Survey

References (5)

1. Van Gaal L, Rissanen AM, Scheen AJ, Ziegler O, Rossner S. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet 2005;365:1389-97.
2. Ramelteon (Rozerem) (package insert). Lincolnshire, Ill.: Takeda Pharmaceuticals North America, July 2005. (Accessed August 8, 2005, at http://www.fda.gov/cder/foi/label/ 2005/021782lbl.pdf.)
3. Carson P, Ziesche S, Johnson G, Cohn JN.Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. J Card Fail 1999;5:178-87.
4. Avorn J. Powerful medicines: the benefits, risks, and costs of prescription drugs. New York: Alfred A. Knopf, 2004.
5. Centers for Medicare & Medicaid Services. Health care industry market update: pharmaceuticals. Baltimore: Centers for Medicare & Medicaid Services, January 2003. (Accessed August 8, 2005, at http://www.cms.hhs.gov/ reports/hcimu/hcimu_01102003.pdf.)