A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance, and Why.

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have robust scientific and technical collaborations. As a window to the impact of these activities we compared the agencies' decisions on drug marketing applications. Decisions were compared for 107 new drug applications with a regulatory outcome at both agencies in the period 2014-2016.

Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013.

This study describes publication rates and characteristics of postmarket drug studies by application type, regulatory authority, study type, and drug class.