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

被引：0

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;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

引用

共 50 条

[1] Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
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Miller, Jennifer E.
Ross, Joseph S.
BMC MEDICINE, 2019, 17 (1)
[2] Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis
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[3] Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
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