The Department of Health and Human Services and National Institutes of Health have issued a final rule and companion policy, respectively, providing more information about clinical trials to the public in an effort at increased transparency.
The HHS final rule, which takes effect on Jan. 18, 2017, expands the legal requirements for submitting registration and results information for clinical trials involving Food and Drug Administration-regulated drug, biological and device products, including adverse event information. However, the requirements do not apply to Phase 1 trials of drug and biological products or small feasibility studies of device products.
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