Clinical Trial Reporting Requirements Finally Getting Teeth

Sept. 21, 2018, 2:23 PM

Drug and device companies could see the FDA start to levy penalties for failing to follow two-year-old requirements designed to shine a spotlight on their clinical trials.

The Food and Drug Administration detailed how it would go after those who violate ClinicalTrials.gov regulations, which require clinical trial sponsors or lead researchers to register their studies on the government-operated database. Failure to follow these rules can result in a penalty of up to $10,000 a day.

Congress established ClinicalTrials.gov nearly two decades ago to help patients and prospective research volunteers access clinical trials.

Clinical trials that are either subject to ...

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