相关参考文献
注意：仅列出部分参考文献，下载原文获取全部文献信息。US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018
Joshua J. Skydel et al.
CLINICAL TRIALS (2021)
Changing FDA Approval Standards: Ethical Implications for Patient Consent
Jonathan J. Darrow et al.
JOURNAL OF GENERAL INTERNAL MEDICINE (2021)
Few new drugs deserve expedited regulatory treatment
Jonathan J. Darrow
JOURNAL OF MANAGED CARE & SPECIALTY PHARMACY (2021)
FDA Approval and Regulation of Pharmaceuticals, 1983-2018
Jonathan J. Darrow et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2020)
Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Audrey D. Zhang et al.
JAMA NETWORK OPEN (2020)
Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs
Bishal Gyawali et al.
ECLINICALMEDICINE (2020)
Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
Joshua D. Wallach et al.
BMC MEDICINE (2019)
Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis
Joshua D. Wallach et al.
JOURNAL OF GENERAL INTERNAL MEDICINE (2019)
Is the number of cancer drug approvals a surrogate for regulatory success?
Bishal Gyawali et al.
JOURNAL OF CANCER POLICY (2019)
Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration
Huseyin Naci et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2017)
Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Nicholas S. Downing et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2017)
Indirect estimation of the prevalence of spinal muscular atrophy Type I, II, and III in the United States
Cathy Lally et al.
ORPHANET JOURNAL OF RARE DISEASES (2017)
The Strength of Association Between Surrogate End Points and Survival in Oncology A Systematic Review of Trial-Level Meta-analyses
Vinay Prasad et al.
JAMA INTERNAL MEDICINE (2015)
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Nicholas S. Downing et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2014)
Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer
Aaron S. Kesselheim et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2011)
The answer is 17 years, what is the question: understanding time lags in translational research
Zoe Slote Morris et al.
JOURNAL OF THE ROYAL SOCIETY OF MEDICINE (2011)
The regulation of patient-reported outcome claims: Need for a flexible standard
LA Morris et al.
VALUE IN HEALTH (2002)
分享论文
