title: The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports.
abstract: OBJECTIVE
  To compare the accessibility, comprehensiveness, and usefulness of data available from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) drug reports.
  
  
  METHODS
  This is a cross-sectional study. All new molecular drugs approved between January 1, 2011 and December 31, 2012 from the FDA and EMA Web sites were eligible.
  
  
  RESULTS
  We included 27 drug reports. Most were searchable, but the FDA table of contents did not match the file's page numbers. Several FDA documents must be searched compared with a single EMA document, but the FDA reports contain more summary data on harms. Detailed information about harms was reported for 93% of the FDA reports (25 of 27 reports) and 26% of the EMA reports (7 of 27 reports). The reports contained information about trial methodology but did not include trial registry IDs or investigator names. All reports but one contained sufficient information to be used in a meta-analysis.
  
  
  CONCLUSIONS
  Detailed data on efficacy and harms are available at the two agencies. The FDA has more summary data on harms, but the documents are harder to navigate.
authors.affiliation: The Nordic Cochrane Centre, Rigshospitalet, Dept 7810, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark. Electronic address: js@cochrane.dk.
authors.forename: Jeppe Bennekou
authors.initials: JB
authors.lastname: Schroll
authors.affiliation: Department of Clinical Pharmacy, University of California, San Francisco, Suite 420, Box 0613, 3333 California Street, San Francisco, CA 94118 USA.
authors.forename: Maher
authors.initials: M
authors.lastname: Abdel-Sattar
authors.affiliation: Department of Clinical Pharmacy, University of California, San Francisco, Suite 420, Box 0613, 3333 California Street, San Francisco, CA 94118 USA; Institute for Health Policy Studies, University of California, San Francisco, Suite 420, Box 0613, 3333 California Street, San Francisco, CA 94118 USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Bero
mesh_terms: D022126:Access to Information; D003430:Cross-Sectional Studies; D004282:Documentation; D017277:Drug Approval; D006801:Humans; D033181:Information Dissemination; D020407:Internet; D004364:Pharmaceutical Preparations; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations
keywords: Drug regulation; EMA; FDA; Harms; Systematic reviews; Unpublished data