STAT+: In response to criticism, FDA publishes new database of wayward clinical trial sponsors
The FDA has launched a dashboard containing preliminary notices sent to companies, universities, and researchers that failed to register clinical trials or report study results.
In a bid toward greater transparency, the U.S. Food and Drug Administration earlier this month launched a dashboard containing preliminary notices sent to companies, universities, and researchers that failed to register clinical trials or report study results.
The agency has so far sent about 120 so-called pre-notices indicating a clinical trial sponsor or investigator failed to comply with a federal law that requires such steps. If follow-up does not occur, the FDA can issue a non-compliance notice and seek penalties. Among those that received a pre-notice were Novartis, Bausch and Lomb, and the Georgetown University Medical Center.
The move comes amid growing complaints that compliance is lacking.
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