Details Basic Details Status Ongoing Last Updated Friday, March 3, 2023 Original Posting Date Friday, March 3, 2023 Health Outcome(s) all congenital malformations, congenital cardiac malformations (primary), congenital urinary malformations (primary) Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR No Analytic Code Link(s) (2) Congenital Malformations Observed in the Mother’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis Congenital Malformations Observed in the Mother’s or Linked Infant’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis