Details Basic Details Status Ongoing Last Updated Monday, November 4, 2024 Original Posting Date Friday, March 3, 2023 Health Outcome(s) congenital cardiac malformations (primary), congenital urinary malformations (primary), all congenital malformations 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 Result(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