Physicians’ Perspectives on FDA Approval Standards and Off-label Drug Marketing-Reference-Cited by-同舟云学术

Physicians’ Perspectives on FDA Approval Standards and Off-label Drug Marketing

Published:2019-05-01 Issue:5 Volume:179 Page:707
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

Kesselheim Aaron S.¹,Woloshin Steven²,Lu Zhigang¹,Tessema Frazer A.¹,Ross Kathryn M.³,Schwartz Lisa M.²

Affiliation:

1. Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

2. The Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire

3. The American Board of Internal Medicine, Philadelphia, Pennsylvania

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Link

http:///jamainternalmedicine/article-pdf/179/5/707/17551163/jamainternal_kesselheim_2019_ld_180078.pdf

Reference6 articles.

1. A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report.;Psaty;JAMA,2012

2. The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.;Wallach;Clin Trials,2018

3. Internal medicine physicians’ financial relationships with industry: an updated national estimate.;Kesselheim;J Gen Intern Med,2018

4. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.;Downing;JAMA,2014

5. Prospects for regulation of off-label drug promotion in an era of expanding commercial speech protection.;Kesselheim;Univ N Carolina Law Rev,2014

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