Overall Safety Assessment – Interactive Safety Graphics for Regulatory Decision-Making

Jeremy Wildfire, Sr. Director of Biostatistics, Gilead, Steve Mallett, Sr. Manager of Statistics, Veramed & Mat Soukup,  Deputy Division Director and Office Biostatistics representative, FDA/CDER join Greg Ball, ASAP Process Consulting, to discuss interactive safety graphics:  industry’s exploration and nascent use, value comparison to traditional static graphics, and exploration of use of interactive safety graphics in submissions and decision making.