SS P08 Hepatotoxicity White Paper
White Paper Title and Lead
Title = Analyses and Displays Associated with Hepatotoxicity – With a Focus on Phase 2-4 Clinical Trials and Integrated Summary Documents
Lead = Terry Walsh, Melvin Munish
FDA Liaison = Eileen Navarro
Creating a first draft for review is in progress.
Targeting May 2014 for a first draft for broad review.
Targeting the end of 2014 for a final white paper.
Several topics were discussed during the PhUSE CSS March 2014 Meeting: See SS P08 18March2014 Standard Scripts Project 08 Meeting for meeting minutes.
Last revised by WendyDobson,10/29/2019