Author:
Phillips Adam T.,Desai Nihar R.,Krumholz Harlan M.,Zou Constance X.,Miller Jennifer E.,Ross Joseph S.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference15 articles.
1. New Drugs: Grounds for Refusing Application; Approval of Application; “Substantial Evidence” Defined, 21 USC §355d.
https://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec355.htm
. Accessed Aug 2016.
2. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078749.pdf
. Accessed Aug 2016.
3. Smithy JW, Downing NS, Ross JS. Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: a cross-sectional study. JAMA Intern Med. 2014;174(9):1518–20.
4. Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open. 2015;5:e009758. doi:
10.1136/bmjopen-2015-009758
.
5. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–60.
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