FDA finalises penalties for clinical trial sponsors that don’t share data, but critics say they fall short

Stat News

18 August 2020 - After a year of deliberation, the FDA released final guidelines for penalising clinical trial sponsors that fail to register studies, do not report results to a government database, or submit false information. 

But transparency experts argued the agency effort falls short in some ways.

The guidance, which notes any company or university that does not provide required information to ClinicalTrials.gov may face a $10,000 fine for each infraction, comes after a long-running effort to push the FDA to penalise violators.

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Michael Wonder

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Michael Wonder