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HHS, NIH expanding mandates

September 16, 2016 7:00 AM UTC

HHS released a final rule that will require some sponsors to report summary clinical results to 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. ...