Details Basic Details Status Ongoing Last Updated Friday, May 8, 2026 Original Posting Date Friday, May 8, 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 Infliximab Biosimilar Product Use: An Active Comparator Signal Identification Analysis