2015
Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study
Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study. Pharmacoepidemiology And Drug Safety 2015, 25: 687-694. PMID: 26554874, DOI: 10.1002/pds.3910.Peer-Reviewed Original ResearchConceptsDear Healthcare Professional CommunicationsEuropean Medicines AgencySafety eventsSafety concernsHealthcare Professional CommunicationsNovel medicinesCentralized authorization procedureEMA websitePostmarket studiesRegulatory reviewPostmarket periodMedicines AgencyWithdrawalSafety communicationMedicineSafety evaluationReview
2014
Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison
Zeitoun JD, Lefèvre JH, Downing N, Bergeron H, Ross JS. Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison. PLOS ONE 2014, 9: e109100. PMID: 25333986, PMCID: PMC4204813, DOI: 10.1371/journal.pone.0109100.Peer-Reviewed Original Research