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Session 2: FDA Electronic Submissions Update
Session Chair(s)
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
Seyoum Senay, MS
Supervisory Operations Research Analyst, CDER/OBI, FDA, United States
This session will provide information related to electronic submissions. Topic areas will address eCTD, ESG, GSRS, CDER Nextgen Portal, and a proof of concept around modernizing the Information Request process. Experts from these areas will discuss recent updates and be available during the FDA Ask the Regulator session to answer questions.
Update on eCTD v3.2.2 & v4.0 Submissions
Jessica Bernhardt, FDA
Updates to eCTD for v3.2.2 and v4.0
Heather Crandall, FDA
FDA CDER NextGen Portal
Seyoum Senay, FDA
FDA’S Global Substance Registration System (GSRS) and Submitting Structure Data (SD) File to have Unique Ingredient Identifiers (UNIIs) for FDA-regulated Products
Siba Bhattacharyya, FDA
FDA CDER Information Request (IR) Modernization: PDUFA VII IR Demonstration Project
Jonathan Resnick, FDA
Learning Objective : - Discuss updates to FDA’s eCTD program including eCTD v4.0, webpage edits, updates to specification and guidance, common validation issues
- Identify updates to CDER’s NextGen Portal and when to use it
- Explain benefits of FDA’s Global Substance Registration System
- Share updates to FDA’s ESG program including transition to ESG NextGen, webpage edits, overall benefits
- Explain how the IR Modernization proof of concept can address pain points
Speaker(s)
Update on eCTD v3.2.2 & v4.0 Submissions
Jessica Bernhardt, MS
IT Project Manager ODT, FDA, United States
Updates to eCTD for v3.2.2 and v4.0
Heather Crandall, MA
Business Informatics Specialist, OBI, FDA, FDA, United States
Global Substance Registration System (GSRS) and Submitting Structure Data File (SDF) to FDA
Siba P Bhattacharyya, PhD
Health Scientist, OC/ODT/ODAR/HIS, FDA, United States
FDA’S Global Substance Registration System (GSRS) and Submitting Structure Data (SD) File to have Unique Ingredient Identifiers (UNIIs) for FDA-regulated Products
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
FDA CDER NextGen Portal
Seyoum Senay, MS
Supervisory Operations Research Analyst, CDER/OBI, FDA, United States
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