Works matching AU Downing, Nicholas S.

Results: 33

Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.

Published in:

JAMA Network Open, 2021, v. 4, n. 6, p. e2113224, doi. 10.1001/jamanetworkopen.2021.13224

By:

Dhodapkar, Meera;
Zhang, Audrey D.;
Puthumana, Jeremy;
Downing, Nicholas S.;
Shah, Nilay D.;
Ross, Joseph S.

Publication type:

Article

Quality of Care in Chinese Hospitals: Processes and Outcomes After ST-segment Elevation Myocardial Infarction.

Published in:

Journal of the American Heart Association, 2017, v. 6, n. 6, p. 1, doi. 10.1161/JAHA.116.005040

By:

Downing, Nicholas S.;
Yongfei Wang;
Dharmarajan, Kumar;
Nuti, Sudhakar V.;
Murugiah, Karthik;
Xue Du;
Xin Zheng;
Xi Li;
Jing Li;
Masoudi, Frederick A.;
Spertus, John A.;
Lixin Jiang;
Krumholz, Harlan M.

Publication type:

Article

National Assessment of Statin Therapy in Patients Hospitalized with Acute Myocardial Infarction: Insight from China PEACE-Retrospective AMI Study, 2001, 2006, 2011.

Published in:

PLoS ONE, 2016, v. 11, n. 4, p. 1, doi. 10.1371/journal.pone.0150806

By:

Zhang, Lihua;
Li, Jing;
Li, Xi;
Nasir, Khurram;
Zhang, Haibo;
Wu, Yongjian;
Hu, Shuang;
Wang, Qing;
Downing, Nicholas S.;
Desai, Nihar R.;
Masoudi, Frederick A.;
Spertus, John A.;
Krumholz, Harlan M.;
Jiang, Lixin;
null, null

Publication type:

Article

Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.

Published in:

2017

By:

Rathi, Vinay K.;
Wang, Bo;
Ross, Joseph S.;
Downing, Nicholas S.;
Kesselheim, Aaron S.;
Gray, Stacey T.

Publication type:

journal article

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.

Published in:

2017

By:

Rathi, Vinay K.;
Bo Wang;
Ross, Joseph S.;
Downing, Nicholas S.;
Kesselheim, Aaron S.;
Gray, Stacey T.;
Wang, Bo

Publication type:

journal article

The china patient-centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design.

Published in:

Catheterization & Cardiovascular Interventions, 2016, v. 88, n. 7, p. E212, doi. 10.1002/ccd.26461

By:

Du, Xue;
Pi, Yi;
Dreyer, Rachel P.;
Li, Jing;
Li, Xi;
Downing, Nicholas S.;
Li, Li;
Feng, Fang;
Zhan, Lijuan;
Zhang, Haibo;
Guan, Wenchi;
Xu, Xiao;
Li, Shu‐Xia;
Lin, Zhenqiu;
Masoudi, Frederick A.;
Spertus, John A.;
Krumholz, Harlan M.;
Jiang, Lixin

Publication type:

Article

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.

Published in:

JAMA Network Open, 2020, v. 3, n. 4, p. e203284, doi. 10.1001/jamanetworkopen.2020.3284

By:

Zhang, Audrey D.;
Puthumana, Jeremy;
Downing, Nicholas S.;
Shah, Nilay D.;
Krumholz, Harlan M.;
Ross, Joseph S.

Publication type:

Article

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

Published in:

British Journal of Clinical Pharmacology, 2015, v. 80, n. 4, p. 716, doi. 10.1111/bcp.12643

By:

Zeitoun, Jean‐David;
Lefèvre, Jérémie H.;
Downing, Nicholas S.;
Bergeron, Henri;
Ross, Joseph S.

Publication type:

Article

Describing the performance of U.S. hospitals by applying big data analytics.

Published in:

PLoS ONE, 2017, v. 12, n. 6, p. 1, doi. 10.1371/journal.pone.0179603

By:

Downing, Nicholas S.;
Cloninger, Alexander;
Venkatesh, Arjun K.;
Hsieh, Angela;
Drye, Elizabeth E.;
Coifman, Ronald R.;
Krumholz, Harlan M.

Publication type:

Article

Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

Published in:

Pharmacoepidemiology & Drug Safety, 2016, v. 25, n. 6, p. 687, doi. 10.1002/pds.3910

By:

Zeitoun, Jean‐David;
Lefèvre, Jérémie H.;
Downing, Nicholas S.;
Bergeron, Henri;
Ross, Joseph S.

Publication type:

Article

Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation.

Published in:

2015

By:

Downing, Nicholas S.;
Krumholz, Harlan M.;
Ross, Joseph S.;
Shah, Nilay D.

Publication type:

journal article

Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013.

Published in:

JAMA: Journal of the American Medical Association, 2015, v. 314, n. 4, p. 355, doi. 10.1001/jama.2015.8035

By:

Krumholz, Harlan M.;
Nuti, Sudhakar V.;
Downing, Nicholas S.;
Normand, Sharon-Lise T.;
Yun Wang

Publication type:

Article

Withdrawal of Personal Genome Service--reply.

Published in:

2014

By:

Downing, Nicholas S;
Ross, Joseph S

Publication type:

commentary

Withdrawal of Personal Genome Service.

Published in:

2014

By:

Downing, Nicholas S.;
Ross, Joseph S.

Publication type:

Letter to the Editor

Trial evidence and approval of therapeutic agents--reply.

Published in:

2014

By:

Downing, Nicholas S;
Ross, Joseph S

Publication type:

commentary

Trial Evidence and Approval of Therapeutic Agents.

Published in:

2014

By:

Downing, Nicholas S.;
Ross, Joseph S.

Publication type:

Letter to the Editor

Innovation, risk, and patient empowerment: the FDA-mandated withdrawal of 23andMe's Personal Genome Service.

Published in:

2014

By:

Downing, Nicholas S;
Ross, Joseph S

Publication type:

journal article

Innovation, Risk, and Patient Empowerment.

Published in:

2014

By:

Downing, Nicholas S.;
Ross, Joseph S.

Publication type:

Opinion

Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Published in:

2014

By:

Downing, Nicholas S;
Aminawung, Jenerius A;
Shah, Nilay D;
Krumholz, Harlan M;
Ross, Joseph S

Publication type:

journal article

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents. 2005-2012.

Published in:

JAMA: Journal of the American Medical Association, 2014, v. 311, n. 4, p. 368, doi. 10.1001/jama.2013.282034

By:

Downing, Nicholas S.;
Aminawung, Jenerius A.;
Shah, Nilay D.;
Krumholz, Harlan M.;
Ross, Joseph S.

Publication type:

Article

Organizational culture in cardiovascular care in Chinese hospitals: a descriptive cross-sectional study.

Published in:

2015

By:

Yin, Emily S.;
Downing, Nicholas S.;
Xi Li;
Singer, Sara J.;
Curry, Leslie A.;
Jing Li;
Krumholz, Harlan M.;
Lixin Jiang;
Li, Xi;
Li, Jing;
Jiang, Lixin

Publication type:

journal article

Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

Published in:

International Journal of Cancer, 2018, v. 142, n. 2, p. 414, doi. 10.1002/ijc.31061

By:

Zeitoun, Jean‐David;
Baron, Gabriel;
Vivot, Alexandre;
Atal, Ignacio;
Downing, Nicholas S.;
Ross, Joseph S.;
Ravaud, Philippe

Publication type:

Article

Cancer Therapeutic Clinical Trials Supporting FDA Approval and Compendia Inclusion.

Published in:

American Journal of Pharmacy Benefits, 2017, v. 9, n. 4, p. 122

By:

Su, Kevin W.;
Gross, Cary P.;
Downing, Nicholas S.;
Adelson, Kerin B.;
Ross, Joseph S.

Publication type:

Article

Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals.

Published in:

2016

By:

Downing, Nicholas S.;
Shah, Nilay D.;
Neiman, Joseph H.;
Aminawung, Jenerius A.;
Krumholz, Harlan M.;
Ross, Joseph S.

Publication type:

journal article

Characteristics of Novel Therapeutics and Postmarket Safety Events-Reply.

Published in:

2017

By:

Downing, Nicholas S.;
Shah, Nilay D.;
Ross, Joseph S.

Publication type:

Letter

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

Published in:

2017

By:

Downing, Nicholas S.;
Shah, Nilay D.;
Aminawung, Jenerius A.;
Pease, Alison M.;
Zeitoun, Jean-David;
Krumholz, Harlan M.;
Ross, Joseph S.

Publication type:

journal article

New and incremental FDA black box warnings from 2008 to 2015.

Published in:

Expert Opinion on Drug Safety, 2018, v. 17, n. 2, p. 117, doi. 10.1080/14740338.2018.1415323

By:

Solotke, Michael T.;
Dhruva, Sanket S.;
Downing, Nicholas S.;
Shah, Nilay D.;
Ross, Joseph S.

Publication type:

Article

Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis.

Published in:

Clinical Pharmacology & Therapeutics, 2018, v. 104, n. 5, p. 1000, doi. 10.1002/cpt.1038

By:

Zeitoun, Jean‐David;
Atal, Ignacio;
Vivot, Alexandre;
Ravaud, Philippe;
Baron, Gabriel;
Ross, Joseph S.;
Downing, Nicholas S.

Publication type:

Article

Coronary Catheterization and Percutaneous Coronary Intervention in China: 10-Year Results From the China PEACE-Retrospective CathPCI Study.

Published in:

2016

By:

Xin Zheng;
Curtis, Jeptha P.;
Shuang Hu;
Yongfei Wang;
Yuejin Yang;
Masoudi, Frederick A.;
Spertus, John A.;
Xi Li;
Jing Li;
Dharmarajan, Kumar;
Downing, Nicholas S.;
Krumholz, Harlan M.;
Lixin Jiang;
Zheng, Xin;
Hu, Shuang;
Wang, Yongfei;
Yang, Yuejin;
Li, Xi;
Li, Jing;
Jiang, Lixin

Publication type:

journal article

Market Exclusivity for Top-Selling Pharmaceuticals Too Long, Too Short, or Just Right?

Published in:

JAMA Internal Medicine, 2015, v. 175, n. 4, p. 637, doi. 10.1001/jamainternmed.2014.7972

By:

Downing, Nicholas S.

Publication type:

Article

Publication of Pivotal Efficacy Trials for Novel Therapeutic Agents Approved Between 2005 and 2011: A Cross-sectional Study.

Published in:

JAMA Internal Medicine, 2014, v. 174, n. 9, p. 1518, doi. 10.1001/jamainternmed.2014.3438

By:

Smithy, James W.;
Downing, Nicholas S.;
Ross, Joseph S.

Publication type:

Article

Descriptions and interpretations of the ACCORD-Lipid trial in the news and biomedical literature: a cross-sectional analysis.

Published in:

2014

By:

Downing, Nicholas S;
Cheng, Theresa;
Krumholz, Harlan M;
Shah, Nilay D;
Ross, Joseph S

Publication type:

journal article

Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature A Cross-Sectional Analysis.

Published in:

JAMA Internal Medicine, 2014, v. 174, n. 7, p. 1176, doi. 10.1001/jamainternmed.2014.1371

By:

Downing, Nicholas S.;
Theresa Cheng;
Krumholz, Harlan M.;
Shah, Nilay D.;
Ross, Joseph S.

Publication type:

Article