Results May Vary, But Reporting Shouldn’t: FDA Sends a Not-So-Gentle Reminder on ClinicalTrials.gov Compliance By Sarah Wicks & David B. Clissold —

https://www.thefdalawblog.com/2026/04/results-may-vary-but-reporting-shouldnt-fda-sends-a-not-so-gentle-reminder-on-clinicaltrials-gov-compliance/?utm_source=rss&utm_medium=rss&utm_campaign=results-may-vary-but-reporting-shouldnt-fda-sends-a-not-so-gentle-reminder-on-clinicaltrials-gov-compliance FDA has, once again, reminded sponsors that ClinicalTrials.gov results reporting is not optional. In a March 30, 2026 outreach, the Agency contacted more than 2,200 sponsors and investigators associated with over 3,000 clinical trials that appear to be missing required results submissions to ClinicalTrials.gov or have not cleared the National Library of Medicine’s quality control process. As FDA put it, these communications were intended to prompt “voluntary compliance” with long-standing statutory and regulatory requirements.