FDA/CDER SEND PilotFDA/CDER SEND Pilot - CDISC
First FDA SEND Pilot • FDA involved in SEND since 2002 • Original pilot began in 2003 • SEND IG 2 3SEND IG 2.3 • Simulated study data •1st iteration of ToxVision – Developed under a CRADA with PharmQuestDeveloped under a CRADA with PharmQuest ................
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