Remedies needed to address the pathology in reporting adverse reactions and food and drug administration use of reports

Journal of General Internal Medicine

Volumn 18, Issue 1, 2003, Pages 72-73

  Wolfe, Sidney M ^a  

^a Public Citizen Health Research Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG APPROVAL; DRUG SURVEILLANCE PROGRAM; ERROR; FOOD AND DRUG ADMINISTRATION; MEDICAL LITERATURE; PHYSIOLOGY; RISK ASSESSMENT; TAXONOMY;

EID: 0037241593     PISSN: 08848734     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1525-1497.2003.21115.x     Document Type: Article

References (7)

1. Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration: Your report can make a difference. J Gen Intern Med. 2003;18:56-9.
2. Thomas EJ, Petersen LA. Measuring errors and adverse events in health care. J Gen Intern Med. 2003;18:60-6.
3. Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al. Physician reporting of adverse drug reactions. Results of the Rhode Island Adverse Drug Reaction Reporting Project. JAMA. 1990;263:1785-8.
4. Lurie P, Sasich LD. Safety of FDA-approved drugs. JAMA. 1999;282:2297-8.
5. Who owns the FDA? The drug industry or the people? BMJ. 2002;325:555-6, 561, 592-595.
6. Horton R. Lotronex and the FDA. A fatal erosion of integrity. Lancet. 2001;357:1544-5.
7. Quality Assurance Program. Recruitment and Retention of CDER Reviewers: Final Report (FDA); 2001.