Expediting SEND Datasets for an International Regulatory Submission

A case study with Peg Biomedical Co., Ltd Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.   While business between Peg Bio and Covance first started in 2014, the strength and …

What’s Changing in SEND 3.1?

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 test submission with Covance. Photo of binary code

The Tale of a Real-life SEND Test Submission

What to Expect When Submitting Your First SEND Dataset to the FDA With the December 17, 2016* requirement for the FDA Standard for the Exchange of Nonclinical Data (SEND*) fast-approaching, our Covance SEND action team prepared a dataset for test submission to the FDA. This helped us to better understand …