The Food and Drug Administration is requesting data in electronic format with IND and NDA submissions to be considered for fast track approvals. The Standard for Exchange of Nonclinical Data (SEND) Consortium is piloting a SEND Implementation Guide (IG) for DART studies. Many Teratology scientists have been involved in creating the DART SENDIG and have been collaborating in harmonizing the Fetal Pathology lexicons across many pharmaceutical companies.
The SEND Implementation User Group team, part of the FDA/PhUSE CSS’s Nonclinical Working Group, has announced the SEND Implementation Forum site:
This site, moderated by the SEND Implementation User Group, allows for members of the industry who are implementing SEND in their organizations to:
- Ask questions and receive answers from experts
- Subscribe to keep up to date
This forum is a companion to the SEND Implementation Wiki, which remains an evolving knowledge base resource for SEND Implementation, including:
- Fundamentals pages – providing entry-level descriptions of fundamental concepts in SEND, such as SEND itself, Controlled Terminology (CT), and Define.xml
- Getting SEND-ready – with key considerations for new implementers when getting started
- FAQ – providing a large, evolving list of commonly asked questions
- (New) News – providing continual updates relevant to SEND implementation, such as FDA and CDISC updates.