HHS, NIH expanding ClinicalTrials.gov mandates

HHS released a final rule that will require some sponsors to report summary clinical results to ClinicalTrials.gov regardless of whether a compound or device has been approved.

The rule applies to interventional studies of drugs, biological products, and devices that are regulated by FDA. It excludes Phase I studies of drugs and biological products and small feasibility studies of devices, and data for products being evaluated under expanded access protocols. ...