The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports

Journal of Clinical Epidemiology

Volumn 68, Issue 1, 2015, Pages 102-107

  Schroll, Jeppe Bennekou ^a   Abdel Sattar, Maher ^b   Bero, Lisa ^b  

^a Rigshospitalet   (Denmark)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Drug regulation; EMA; FDA; Harms; Systematic reviews; Unpublished data

Indexed keywords

ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; DRUG;

ARTICLE; CONFLICT OF INTEREST; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; DATA BASE; DRUG APPROVAL; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL DOCUMENTATION; MEDICAL INFORMATION; RISK MANAGEMENT; ACCESS TO INFORMATION; DOCUMENTATION; INFORMATION DISSEMINATION; INTERNET; UNITED STATES;

ACCESS TO INFORMATION; CROSS-SECTIONAL STUDIES; DOCUMENTATION; DRUG APPROVAL; HUMANS; INFORMATION DISSEMINATION; INTERNET; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84916208957     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2014.06.019     Document Type: Article

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