(1) If a manufacturer of an investigational drug or investigational device provides an investigational drug or investigational device to a patient located in the state to treat an eligible illness, the manufacturer shall report the information described in Subsection (2) to the Health and Human Services Interim Committee before the November 1 that follows the day the drug or device was provided to the patient. (2) The report shall include the following information: (a) the number of patients that received an investigational drug or investigational device to treat an eligible illness; (b) each eligible illness being treated; (c) adverse outcomes likely attributable to the investigational drug or investigational device; and (d) any other information the manufacturer determines relevant. (3) Subsection (1) does not apply if the patient receiving the device or drug was part of an investigation conducted under 21 C.F.R. Part 812 or a clinical investigation conducted under 21 C.F.R. Part 312.
‹ Prev All Utah sections Next ›
Lexace provides legal information, not legal advice, and no attorney–client relationship is created. Statute text is provided for general information and may not reflect the most recent amendments; verify against the official state code.