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PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
FDA is committed to achieve the long-term goal of improving the predictability and consistency of the electronic submission process and enhancing transparency and accountability of FDA information technology related activities. The PDUFA VI Section IV Information Technology goals focus on following areas: 1. Electronic Submission process from Gateway (ESG) to FDA Center, 2. Technical rejection of submissions process and validation criteria, 3. Electronic system status, performance and metrics, and 4. Data standards, adoption and conformance. This session will provide an overview of the FDA electronic submission systems and data standards that impact sponsors applications from time of submission at the ESG through the time the submission is made available to the review team.
Learning Objective : Describe the electronic submission process including key milestones; Explain the electronic submission gateway submission upload timeframes, notifications to sponsors and rejection process; Discuss the data standards catalog and action for industry.
Speaker(s)
FDA Update
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
FDA Update
Ethan Chen, MBA, MS, PMP
FDA, United States
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
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