Electronic Submission Capability to FDA for Academic Investigators-The Process, Challenges, and Opportunities Affecting the Translational Research Enterprise.

The article discusses the regulatory support program at a large academic health center and its acquisition of eSub capability for drugs and devices. It describes the steps involved and the challenges and explores the use of expert technical consulting and software solutions. Moreover, it examines the impact of eSubmissions on the regulatory operations metrics, agency interaction and industry interaction.