FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty

Lexology

27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after the study’s primary completion date. 

In the past, some companies delayed updating a clinical trial record, including by failing to update the primary completion date to reflect delays or failing to submit results within 12 months of that date.

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Michael Wonder

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Michael Wonder