The FDA Animal Rule And Standard For Exchange Of Nonclinical Data (SEND)

By Karalyne Crowder, Li Zhan, and KD. Thrall

The Standard for Exchange of Nonclinical Data (SEND) is now required for FDA submissions of carcinogenicity and toxicity studies, aiming to standardize and digitize data for regulatory review. While not yet mandated for Animal Rule studies, there is growing interest in using SEND for data visualization and storage. However, acute radiation syndrome (ARS) studies present challenges under the current SEND framework, including the inability to designate Day 0 for radiation exposure and the lack of standardized modeling for challenge agents and test articles.

Existing SEND guidelines also restrict the introduction of new domains, requiring unconventional use of current categories for critical data elements like medical history and microbiology samples. To address these issues, a CDISC Animal Rule team is developing guidance to standardize SEND implementation for ARS studies, which will undergo FDA and public review before becoming a requirement.