FDAAA 801 Compliance Outreach and Impact Analysis

By: UAEM Clinical Trials Transparency Committee

August 4, 2026

Summary

Clinical trial transparency is a key pillar of ethical research. When trial results are reported publicly, patients, clinicians, researchers, and policymakers can make more informed decisions about the safety and effectiveness of medical interventions. Under Section 801 of the Food and Drug Administration Amendments Act, commonly known as FDAAA 801, responsible parties for applicable clinical trials are legally required to submit summary results and adverse event information to ClinicalTrials.gov within 12 months of a trial’s primary completion date. If non-compliant, the FDA can enforce monetary penalties and potentially withhold future grant funding.

Although these legal requirements exist, noncompliance remains widespread, largely due to limited enforcement. To hold clinical trial sponsors accountable for their full reporting requirements, UAEM led a targeted campaign using data from the FDAAA TrialsTracker to push sponsors with significant noncompliance to improve reporting behavior. 

Overall compliance among the 39 sponsors increased by an average of 2.17% between December 2025 and March 2026. Several institutions showed notable improvements after receiving outreach, while others remained stagnant or declined.