Posted by Michael Wonder on 15 May 2017
Publication and reporting of the results of post-market studies for drugs required by the US FDA, 009 to 2013
15 May 2017 - 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 FDA is authorised to require post-market studies, including submission of status reports and final results. Sponsors of certain applicable clinical trials are also required to publish summary results at the ClinicalTrials.gov website.
Amid increasing calls for transparency in research, we describe publication rates and characteristics of post-market drug studies.
