Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

Risk Management Plans as a Tool for Proactive Pharmacovigilance: A Cohort Study of Newly Approved Drugs in Europe

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Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

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Antidepressants' Black-Box Warning — 10 Years Later

(2014) Richard A. Friedman   NEW ENGLAND JOURNAL OF MEDICINE

Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison

(2014) Jean-David Zeitoun et al.   PLoS One

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

(2013) Ruben G. Duijnhoven et al.   PLOS MEDICINE

Additional safety risk to exceptionally approved drugs in Europe?

(2011) Arna H. Arnardottir et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

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(2011) J Raine et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Safety-Related Regulatory Actions for Orphan Drugs in the US and EU

(2010) Harald E. Heemstra et al.   DRUG SAFETY

Risk Management Plans: are they a tool for improving drug safety?

(2010) Serena Frau et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union

(2008)   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Drug-Review Deadlines and Safety Problems

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The risk we bear: The effects of review speed and industry user fees on new drug safety

(2007) Mary K. Olson   JOURNAL OF HEALTH ECONOMICS