Proposed Rule Re Submitting Clinical Trial Registration and Results, Including Adverse Event Information, To ClinicalTrials.gov Database
As mentioned on our Health Industry Washington Watch blog, the National Institutes of Health has released a proposed rule designed to provide clarity on the requirements surrounding the submission of information to ClinicalTrials.gov, as mandated by the Food and Drug Administration Amendments Act of 2007.
Among the proposed requirements is summary results submission for clinical trials involving all pharmaceuticals, medical devices and biological products, regardless of whether they have been approved, licensed or cleared by the Food and Drug Administration, timetable restrictions for the registration of a clinical trial and submission of summary results, and guidelines for the reporting of adverse events.
The proposed rule will officially be published on November 21, 2014, and comments will be accepted for 90 days thereafter.
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