1 Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA. jenn.sellers@fda.hhs.gov.
2 Inspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
3 Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.