Regulatory Submission Blog

Marking 25 years in nonclinical and 10 years with SEND, Marc reflects on how far the industry, and SEND itself, has come, and what lies ahead.

New SEND standards are nearing publication, including updates for genetic toxicology, tumor combinations, and the much-anticipated SENDIG-DART v1.2.

This week’s reflections explore how the words we use, like “dataset” and “conversion”, can shape our understanding of SEND, sometimes in misleading ways.

Can we standardize clinical signs data for cross-study analysis, or is the variability just too great? A bold new proposal sparks debate.

Two years after the FDA clarified SEND requirements, questions still linger, especially for less-typical studies and how far customization can go.

SEND and SDTM look strikingly similar, but are we truly leveraging their alignment to connect nonclinical and clinical insights?