Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Aug 1;177(8):1207-1210.
doi: 10.1001/jamainternmed.2017.1313.

Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013

Marisa L Cruz  1 , Jing Xu  1 , Mwango Kashoki  2 , Peter Lurie  1
Affiliations

Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013

Marisa L Cruz et al. JAMA Intern Med. .

Abstract

This study describes publication rates and characteristics of postmarket drug studies by application type, regulatory authority, study type, and drug class.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

References

    1. Expanded clinical trial registry data bank. In US Food and Drug Administration Amendments Act of 2007. Public Law No. 110-85, section 801. https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf. Accessed August 1, 2016.
    1. Institute of Medicine Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Press; 2015. - PubMed
    1. “Reportable” post-market studies are those subject to the reporting requirements under section 506B of the Federal Food, Drug, and Cosmetic Act. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat.... Accessed August 1, 2016.
    1. 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):1518-1520. - PMC - PubMed
    1. Quesada O, Yang E, Redberg RF. Availability and dissemination of results from US Food and Drug Administration-mandated postapproval studies for medical devices. JAMA Intern Med. 2016;176(8):1221-1223. - PubMed

MeSH terms