FDA signals heightened enforcement focus on ClinicalTrials.gov compliance

The U.S. Food and Drug Administration (FDA) recently reminded more than 2,200 clinical trial sponsors to submit clinical trial results to ClinicalTrials.gov. The reminders follow an agency analysis finding that nearly 30% of studies that are “highly likely” to be subject to mandatory ClinicalTrials.gov reporting requirements have no results posted. In prior guidance, FDA indicated that it would more definitively assess potential violations during inspections conducted as part of its Bioresearch... By: Hogan Lovells