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US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

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第一作者： Joshua J,Skydel

第一单位： Tufts University School of Medicine, Boston, MA, USA.

作者： Joshua J,Skydel ^[1] ; Audrey D,Zhang ^[2] ; Sanket S,Dhruva ^[3] ; Joseph S,Ross ^[4] ; Joshua D,Wallach ^[5]

作者单位： Tufts University School of Medicine, Boston, MA, USA. ^[1] Duke University Health System, Durham, NC, USA. ^[2] Section of Cardiology, San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA.;Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA. ^[3] Section of General Internal Medicine, Yale School of Medicine, New Haven, CT, USA.;National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.;Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.;Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA. ^[4] Department of Environmental Health Sciences, Yale School of Public Health, New Haven, CT, USA. ^[5]

关键词 The US Food and Drug Administration clinical evidence clinical trials pharmaceutical regulation postmarketing commitments postmarketing requirements