FDAnews Drug Daily Bulletin

Sponsors Who Don’t Report Trial Data Could Be Hit With Fines, FDA Says

Sept. 24, 2018

Failure to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in draft guidance.

The agency outlined when an FDA center may seek civil monetary penalties and said the centers will generally identify violations through evidence collected in routine Bioresearch Monitoring Program (BIMO) inspections, as well as in the course of complaint investigations.

The agency said it plans to prioritize cases where sponsors have failed to submit trial registration or results for higher-risk trials, repeat noncompliance offenders, and sponsors whose noncompliance is part of broader noncompliance within the trial.

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