No. FDAAA 801 applies to any clinical study that meets the definition of an Applicable Clinical Trial and that was initiated after September 27, 2007, or that was initiated on or before that date and was still ongoing as of December 26, 2007. FDAAA 801 does not distinguish between types of sponsors or funding sources in establishing requirements for registration and results submission.

For complete statutory definitions and more information on the meaning of Applicable Clinical Trial, see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF).