Sidelining safety - The FDA's inadequate response to the IOM

New England Journal of Medicine

Volumn 357, Issue 10, 2007, Pages 960-963

  Smith, Sheila Weiss ^a,b  

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^b UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEXFENFLURAMINE; ROFECOXIB; TROGLITAZONE;

DIABETES MELLITUS; DRUG APPROVAL; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; FUNDING; GOVERNMENT REGULATION; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HEALTH SERVICE; MEDICAL ERROR; OBESITY; PAIN; PATIENT SAFETY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT;

EID: 34548395943     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp078157     Document Type: Article

References (5)

1. Baciu A, Stratton K, Burke SP, eds. The future of drug safety: promoting and protecting the health of the public. Washington DC: National Academies Press, 2006.
2. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health system. Washington, DC: National Academy Press, 1999.
3. The future of drug safety - promoting and protecting the health of the public: FDA's reponse to the Institute of Medicine's 2006 report. Rockville, MD: Food and Drug Administration, January 2007. (Accessed August 16, 2007, at http://www.fda.gov/oc/reports/iom013007.pdf.)
4. Center for Drug Evaluation and Research. CDER 1997 report to the nation: improving public health through human drugs. Rockville, MD: Food and Drug Administration, 1998. (Accessed August 16, 2007, at http://www.fda.gov/cder/ reports/rptntn97.pdf.)
5. Independent verification and validation of AERS II requirements process. Breckenridge, CO: Breckenridge Institute, November 2006. (Accessed August 16, 2007, at http://www.senate.gov/~finance/press/Bpress/2007press/prb030707a.pdf.)