A district court in New York has ruled that drug and clinical trial sponsors cannot avoid their obligation to submit “basic results” about the outcome of trials for approved products between September 27, 2007, when a statute requiring publication of this information on ClinicalTrials.gov went into effect, and January 18, 2017, when regulations finally went into effect to implement the statute.
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New York Judge Holds Additional Clinical Trial Results Must Be Reported to Public FDA Database Posted on: March 31, 2020 In: Intellectual Property & Technology
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