FDA

FDA published guidance regarding Civil Money Penalties relating to the ClinicalTrials.gov repository

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In February the Department of Human Health & Services and the FDA lost a lawsuit regarding missing clinical trial data in the ClinicalTrials.gov repository, which I wrote about here. Prior to the judges’ decision, despite the transparency requirements, FDA has never imposed a fine on a clinical trial’s sponsor, and the National Institutes of Health …

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Federal judge rules clinical trial sponsors must publish 10 years worth of missing data

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For over 10 years, mandatory reporting of clinical trial results to ClinicalTrials.gov had been part of Federal law. However, the FDA has never taken any enforcing action against parties not abiding to this requirement. Unsurprisingly, a piece of law that is not enforced is often ignored. Now plaintiffs Peter Lurie, a former associate FDA commissioner …

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