A Guide To SEND, The Standard For Exchange Of Nonclinical Data

The Standard for Exchange of Nonclinical Data (SEND) – an FDA standard data format/ terminology that is now required for submission of preclinical study data to the FDA – seeks to increase efficiency and the quality of scientific review by the Center for Drug Evaluation and Research (CDER) pharmacologists and toxicologists, and to improve communication between the US Food and Drug Administration (FDA) and the industry. The ultimate goal is to phase out paper submissions.

As an evolving standard, it may take some time for both the FDA and the industry to fully realize SEND benefits. Ideally, SEND will enable a standard mechanism for review of data, as well as more in-depth analysis of data, for FDA. SEND also aims to improve communication efficiencies for vendors and increase time to market.

It is critical that you are aware of the most current submission requirements for both CDER and CBER divisions within the FDA. In particular, Non-GLP Toxicology and DART studies must now follow these guidelines.