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FDA Press Releases·

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov

Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Janet Woodcock M.D. Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise. Across all types of medical product trials, the U.S. Food and Drug Administration works with responsible parties to encourage compliance with the requirements to submit registration and summary results information to the ClinicalTrials.gov data bank, managed by the National Institutes of Health (NIH)/National Library of Medicine. Sponsors of clinical...