Defining Substances and Organizing Regulatory Information: The deployment of the G-SRS at FDA.
The presentation will address why we are implementing the G-SRS. The current status at FDA, migration of data, integration of the G-SRS with other FDA data and systems. Plans for implementing specified substance groups 2, 3 and 4 and plans to capture more CMC and pharmacology within the SRS. We will also have a demo of the system at FDA.