Abstract
Submission of the SEND dataset packages to the FDA became mandatory for embryo-fetal development (EFD) studies starting from March 15, 2023, and many facilities had started to create SEND datasets for EFD studies based on the SENDIG-DART v1.1. However, since SENIG-DART v1.1 is the first FDA supported implementation guide for developmental and reproductive toxicology studies and does not always address everything to detail at this point, SEND preparers may feel uncertain about how to represent data in various instances. In the meantime, the SENDIG-DART v1.2 was updated to cover juvenile toxicology studies on the heels of EFD studies and finalized in June 2023. Although DART v1.2 introduces only 1 new domain, the Developmental Milestones (DP) domain, a number of changes were made in DART v1.2, including information that supplements the contents of DART v1.1. Accordingly, it requires more time than we expected to understand a complete picture of its contents.
For this reason, we compared SENDIG-DART v1.1 against v1.2 to understand what has changed and discussed the specific approaches to address those changes.
In this presentation, we introduce the changes we evaluated and results of our discussion on the following 3 points:
-Study types supported by SENDIG-DART v1.2
-Points to consider in creation of the DP (Developmental Milestone) domain data
-Changes in the existing domains and contents clarified by those changes
