FDA gives a mixed response to petition seeking greater clinical trial transparency

The U.S. Food and Drug Administration stated that it does not plan to impose stricter penalties against clinical trial sponsors and researchers who fail to register studies or report results. This decision is based on potential strain on resources. The agency prefers to rely on voluntary compliance and retains the right to exercise regulatory discretion in considering penalties. However, it did agree to create a dashboard to contain notices for non-compliance. This decision comes in response to an advocacy group’s citizen petition. FDA officials emphasize their goal of achieving timely voluntary compliance without resorting to legal action, as it could be resource-intensive and time-consuming.

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