Details Basic Details Status Ongoing Last Updated Monday, April 6, 2026 Original Posting Date Monday, April 6, 2026 Health Outcome(s) signal identification Purpose Signal Identification Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR No Analytic Code Link(s) (1) Outcome Monitoring Following Prucalopride and Plecanatide Use: An Active Comparator Signal Identification Analysis with Alternating Exposure-Comparator Roles