SEND [Standard for Exchange of Nonclinical Data] is more than just a tool to facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and yield important insights.
The SEND [Standard for Exchange of Nonclinical Data] Implementation Guide v3.1, “SEND 3.1,” changes the model for the reporting of cardiovascular and respiratory endpoints.
SEND 3.1 became effective 15 March 2019 for NDA/BLA submissions; and it will become effective 15 March 2020 for IND submissions, overlapping with the effective period of the previous version, SEND 3.0. (See chart below.)
Chart 1. SEND 3.0 and 3.1 roll-outs.
Some additional regulatory considerations during this transition period include:
- The SEND version required for your submission is determined by the study start date (aka protocol finalization date).
- If you are including non-GLP studies in a regulatory submission, a SEND dataset is also required.
- If you have legacy studies in your submission, an abbreviated TS file (Trial Summary file) is required for each one.