The U.S. Food and Drug Administration told an advocacy group that it is not planning to take a tougher stance against wayward clinical trial sponsors and investigators that fail to register studies or report results, a central issue in the ongoing debate over greater transparency into clinical research.
In response to a citizen’s petition filed a year ago, the agency indicated it is unlikely to levy fines or take a more stringent approach to issue so-called non-compliance notices because the process could strain its resources. Instead, agency officials explained that they prefer to rely on voluntary compliance while retaining the right to exercise regulatory discretion when considering penalties for disclosure violations.
“As in all areas that FDA regulates, the agency’s goal is to achieve timely voluntary compliance with the law without having to resort to legal action, which can be resource intensive and time-consuming,” FDA officials wrote. However, they granted a request to create a dashboard containing notices sent to companies, universities, and researchers that fail to register clinical trials or report study results.
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