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HHS, NIH propose changes to make more clinical trial data available
The Department of Health and Human Services and the National Institutes of Health are releasing two proposals for public comment designed to increase the transparency of clinical trials through the submission of data to ClinicalTrials.gov and increase access to clinical trial data.The first is a notice of proposed rulemaking that describes proposed regulations for registering and submitting results of certain clinical trials to ClinicalTrials.gov that are subject to Title VIII of the FDA Amendments Act of 2007 (FDAAA). It provides proposed interpretations of requirements and practices for submitting registration and (Read more...)