Regulatory Submission Blog

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?

SEND has come a long way since 2012, now more complex, but with better tools, training, and support for those just diving in.

Define.xml is often overlooked in nonclinical submissions, but with the right mindset and tools, it can become a powerful asset for regulatory review.