Chart Review of Major Congenital Malformations

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products. FDA committed to the “Enhancement and modernization of the FDA drug safety system.” The enhancement and modernization include an effort to optimize the Sentinel Initiative and describes a focus on supporting FDA’s monitoring of medical product safety during pregnancy.

As part of these enhancements, FDA is developing a framework addressing how to optimize use of postapproval pregnancy safety studies. The Sentinel System is conducting six demonstration projects to inform this pregnancy framework and address gaps in knowledge about performance characteristics of different study designs. Project six aims to validate performance of the algorithm for identifying composite major congenital malformations (MCM) using ICD-10-CM diagnoses codes in administrative claims data by conducting a chart review and Patient Episode Profile Retrieval (PEPR) review.