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

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood; however, the strength of the clinical trial evidence supporting approval decisions by the US Food and Drug Administration (FDA) has not been evaluated.

Related collections

Author and article information

Journal

Journal ID (iso-abbrev): JAMA

Title: JAMA

ISSN (Electronic): 1538-3598

ISSN (Print): 0098-7484

Publication date (Electronic):

Volume: 311

Issue: 4

Affiliations

[1 ] Yale University School of Medicine, New Haven, Connecticut.

[2 ] Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine.

[3 ] Division of Health Care Policy and Research, Mayo Clinic, Rochester, Minnesota.

[4 ] Division of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine4Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine5Section of Health Policy and Admini.

[5 ] Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine4Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine5Section of Health Policy and Admin.

Article

Publisher Item ID: 1817794 Mid ID: NIHMS566843

DOI: 10.1001/jama.2013.282034

PubMed ID: 24449315

SO-VID: 7970163c-1116-4ca2-a14d-44b19d3fc697

History

Data availability:

Comments

Comment on this article

scite_

Smart Citations

Citing PublicationsSupportingMentioningContrasting

View Citations

See how this article has been cited at scite.ai

scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.