Learning Tracks

Updates on Electronic Submissions

Tuesday, October 3, 2023

11:00 a.m. - 12:00 p.m.

FDA’s Office of Business Informatics (OBI) provides a critical service to facilitate applicants’ electronic submissions. These submissions span from pre-ANDA and pre-BLA submissions into the post-marketing arena. In this session, representatives from OBI will provide updates on: 1) eCTD metrics, top submission errors, and what’s new on FDA’s eCTD webpage; 2) FDA’s implementation of eCTD v4.0;  and 3) evolution of CDER’s NextGen Portal for submission of content not part of an application (e.g. volume information, controlled correspondence, and more).


Megan Boals MPH, MS, CSM, CSPO, A-CSPO
Operations Research Analyst, DDQCSS, OBI, OSP, CDER, FDA

Heather Crandall
Operations Research Analyst, DDMSS, OBI, OSP, CDER, FDA

Seyoum Senay
Supervisory Operations Research, DDMSS, OBI, OSP, CDER, FDA

Jonathan Resnick, PMP
Project Management Officer, DDMSS, OBI, OSP, CDER, FDA