The U.S. Department of Health and Human Services issued a final rule for registering and reporting summary results information for certain clinical trials involving U.S. Food and Drug Administration-regulated drug, biological and device products to ClinicalTrials.gov. Additionally, the National Institutes of Health issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule. The National Center for Advancing Translational Sciences (NCATS), which funds the CTSA program, is encouraging its stakeholders to learn more about these important policy developments by reading the NIH news release and related materials, including JAMA and New England Journal of Medicine articles.
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