Efficacy And Safety Concerns Are Important Reasons Why The FDA Requires Multiple Reviews Before Approval Of New Drugs-Reference-Cited by-同舟云学术

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Efficacy And Safety Concerns Are Important Reasons Why The FDA Requires Multiple Reviews Before Approval Of New Drugs

Published:2015-04 Issue:4 Volume:34 Page:681-688
ISSN:0278-2715
Container-title:Health Affairs
language:en
Short-container-title:Health Affairs

Author:

Ross Joseph S.¹,Dzara Kristina²,Downing Nicholas S.³

Affiliation:

1. Joseph S. Ross ( ) is an associate professor of internal medicine at the Yale University School of Medicine, in New Haven, Connecticut.

2. Kristina Dzara is a research associate in internal medicine at the Yale University School of Medicine.

3. Nicholas S. Downing is a research associate at the Center for Outcomes Research and Evaluation, Yale-New Haven Hospital.

Publisher

Health Affairs (Project Hope)

Subject

Health Policy

Reference15 articles.

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

2. Pharmaceutical Innovation in the 21st Century: New Drug Approvals in the First Decade, 2000–2009

3. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies

4. Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

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