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eCTD Submission Capability to FDA for Academic Sponsor-Investigators: Process, Problems, and Possibilities

Time

Tue, Jun 17 7:15AM
T 40

Title

eCTD Submission Capability to FDA for Academic Sponsor-Investigators: Process, Problems, and Possibilities

Abstract Summary

This project was conducted at a regulatory unit with 30+ IND/IDE submissions and over 150 lifecycle submissions per year. Metrics include labor and/or materials costs for eSub-related document formatting, PDF remediation, publishing (printing vs. eCTD assembly), and materials and shipping costs.

Poster Presenter

E. Mitchell Seymour
PhD, RAC,
Research Faculty; Founder and Principal, R&D Advisors and SciMedLit, LLC,
University of Michigan Medical School
United States