What ails the FDA?

New England Journal of Medicine

Volumn 352, Issue 11, 2005, Pages 1063-1066

  Okie, Susan ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID; ANTIDEPRESSANT AGENT; CERIVASTATIN; CYCLOOXYGENASE 2 INHIBITOR; FENFLURAMINE; ROFECOXIB; TROGLITAZONE;

CARDIOVASCULAR RISK; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; DRUG USE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEART INFARCTION; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; TOBACCO;

ADMINISTRATIVE PERSONNEL; ADOLESCENT; ANTIDEPRESSIVE AGENTS; CYCLOOXYGENASE INHIBITORS; DRUG APPROVAL; DRUG INDUSTRY; FEES AND CHARGES; GOVERNMENT REGULATION; HUMANS; LACTONES; PRODUCT SURVEILLANCE, POSTMARKETING; SULFONES; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 14944360098     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMp058003     Document Type: Review

References (4)

1. Office of Inspector General. FDA's review process for new drug applications: a management review. March 2003. (OEI-01-00590.) (Accessed February 24, 2005, at http://www.oig.hhs.gov/oei/reports/oei-01-01-00590.pdf.)
2. Food and Drug Administration. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies: availability. Fed Regist 2004;69(50):12162-4.
3. Idem. CDER report to the nation: 2003. (Accessed February 24, 2005, at http://www.fda.gov/cder/reports/rtn/2003/rtn2003-3. htm.)
4. Vedantam S. FDA study confirms antidepressant risks: drugs linked to more suicides among children, unpublished analysis says. Washington Post. August 10, 2004:A6.