STAT Plus: FDA finalizes penalties for trial sponsors that don’t share data, but critics say the effort falls short
After a year of deliberation, the Food and Drug Administration released final guidelines for penalizing 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 penalize violators.
