INFECTIOUS DISEASES: Edited by Antoni TorresEvolution and current status of United States Food and Drug Administration and European Medicines Agency regulatory guidance for studies of nosocomial pneumoniaTalbot, George H.Author Information Talbot Advisors LLC, Anna Maria, Florida, USA Correspondence to George H. Talbot, MD, Talbot Advisors LLC, POB 2121, Anna Maria, FL 34216, USA. Tel: +1 610 710 1600; e-mail: [email protected] Current Opinion in Critical Care: October 2018 - Volume 24 - Issue 5 - p 379-384 doi: 10.1097/MCC.0000000000000524 Buy Metrics Abstract Purpose of review Regulatory guidance for design, conduct and analysis of studies of nosocomial pneumonia, including ventilator-associated pneumonia, has undergone substantial evolution over the past three decades. This review summarizes this evolutionary process and the current status of guidance. Recent findings The US Food and Drug Administration and the European Medicines Agency have taken different approaches to defining endpoints for studies of nosocomial pneumonia, especially with regard to the primary endpoint. Both agencies accept a noninferiority design. Independent efforts to develop new endpoints and bridge existing discordances have been fruitful. Summary Transatlantic differences in the approach to study of nosocomial pneumonia complicate study design and analysis, but they will hopefully be resolved in future iterations of regulatory agency guidance. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.