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Research Letter
May 15, 2017

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

Author Affiliations
  • 1Office of Public Health Strategy and Analysis, US Food and Drug Administration, Silver Spring, Maryland
  • 2Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. Published online May 15, 2017. doi:10.1001/jamainternmed.2017.1313

Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research conducted after regulatory approval for marketing. For certain drugs, the US Food and Drug Administration (FDA) is authorized to require postmarket studies, including submission of status reports and final results. Sponsors of certain applicable clinical trials1 are also required to publish summary results at the ClinicalTrials.gov website (https://clinicaltrials.gov/). Amid increasing calls for transparency in research,2 we describe publication rates and characteristics of postmarket drug studies.

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