sNDA Alignment 101: Module 2.5, CCDS, and Labeling
Why you are seeing all these documents in an sNDA An sNDA proposes a change to an already‑approved product , most often a change to the label . FDA therefore expects a clear, traceable story that explains: What is changing Why it should change (based on new data) Where that change is reflected in the submission This is why Module 2.5, CCDS, and US labeling (USPI) are all developed together. The roles of each document (plain language) 1. Module 2.5 – The scientific story What it is: A high‑level clinical overview written for FDA reviewers Explains the totality of evidence ( new studies , ISS, RWE, literature) Describes benefit–risk and why the proposed label change is justified What it is NOT: It does not contain final label wording Think of Module 2.5 as: “Here is the c...