Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

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作者：
Joshua D. Wallach
Anita T. Luxkaranayagam
Sanket S. Dhruva
Jennifer E. Miller
Joseph S. Ross
机构：
[1] Yale School of Public Health,Department of Environmental Health Sciences
[2] Yale Law School,Collaboration for Research Integrity and Transparency (CRIT)
[3] Center for Outcomes Research and Evaluation (CORE),Department of Medicine
[4] Yale-New Haven Hospital,Section of General Medicine, Department of Internal Medicine
[5] University of Connecticut,National Clinician Scholars Program, Department of Internal Medicine
[6] University of California,Department of Health Policy and Management
[7] San Francisco School of Medicine,undefined
[8] Section of Cardiology,undefined
[9] San Francisco Veterans Affairs Health Care System,undefined
[10] Yale School of Medicine,undefined
[11] Yale School of Medicine,undefined
[12] Yale School of Public Health,undefined
来源：
BMC Medicine | / 17卷
关键词：
Postmarketing commitments; Postmarketing requirements; FDA; Lifecycle evaluation; Pharmaceutical regulation;
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