1 Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD, USA. Scott.Janiczak@fda.hhs.gov.
2 Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD, USA.
3 Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
4 Office of Biostatistics, US Food and Drug Administration, Silver Spring, MD, USA.