ClinicalTrials.gov is a registry and results database with over 225,000 studies. It was mandated by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and expanded under the Food and Drug Administration Amendments Act of 2007 (FDAAA).
In 2016, FDAAA 801 described further registration and results requirements. The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11.4) expands and clarifies FDAAA 801 and went into effect January 18, 2017. Results must be entered on ClinicalTrials.gov within 12 months of the Primary Completion Date.