The FDA Drug Safety Bill: How safe are our drugs?

Expert Opinion on Drug Safety

Volumn 7, Issue 4, 2008, Pages 343-346

  Cobert, Barton ^a  

^a Global Regulatory Initiatives and Pharmacovigilance   (United States)

Author keywords

FDA; FDA Amendments Act of 2007; FDA Revitalization Act; PDUFA; User fees

Indexed keywords

CERIVASTATIN; ROFECOXIB; VALDECOXIB;

ACCESS TO INFORMATION; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EDITORIAL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE POLICY; PHARMACEUTICAL CARE; POLITICS; POSTMARKETING SURVEILLANCE; RISK BENEFIT ANALYSIS;

DRUG APPROVAL; DRUG INDUSTRY; HUMANS; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; SAFETY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 48749129187     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.7.4.343     Document Type: Editorial

References (11)

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5. Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med 2008;358:1354-61
6. Available from: http://www.fda.gov/cder/pdufa/ PDUFA_IV_5yr_plan_draft.pdf
7. Available from: http://www.gather.com/ viewArticle.sp?articleId=281474977162229
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10. Available from: http://www.fda.gov/oc/buyonline/faqs.html
11. Available from: http://oversight.house.gov/documents/ 20060721121449-78610.pdf