EPL’s SEND Capabilities

The Standard for Exchange of Nonclinical Data (SEND) provides preclinical study data standards that will allow for a more consistent and streamlined review process by the US FDA.  In general, SEND formats apply to studies started after Dec. 17, 2016 for NDAs, BLAs, and ANDAs, and studies that start after Dec. 17, 2017 for INDs. […]