A. FDA is committed to achieve the long-term goal of improving the predictability and consistency of the electronic submission process (Section IV. B), and enhancing transparency and accountability of FDA information technology related activities (Section IV. C).
B. IMPROVE THE PREDICTABILITY AND CONSISTENCY OF PDUFA ELECTRONIC SUBMISSION PROCESSES
Electronic Submission Documentation
Electronic Submission and System Status
For those systems that sponsors interact with directly, FDA will invite industry to provide feedback and/or participate in user acceptance testing in advance of implementing significant changes that impact industry's interaction with the system. (Section IV.B.6)
- Targets for and Measure ESG Availability overall
- ESG Operational Status
- ESG Service Disruption Instructions
- ESG Scheduled Unavailability and User Interface Changes Process (Section IV.B.6).
ESG Target Timeframes, Milestones and Notifications
- Expected submission upload duration(s) and Timeframe between key milestones and sponsor notifications (Section IV.B.3-4).
C. ENHANCE TRANSPARENCY AND ACCOUNTABILITY OF FDA ELECTRONIC SUBMISSION AND DATA STANDARDS ACTIVITIES
PDUFA VI IT Public Meetings
Hold annual public meetings to seek stakeholder input related to electronic submission system past performance, future targets, emerging industry needs and technology initiatives to inform the FDA IT Strategic Plan and published targets. The following are the scheduled dates of the annual public meetings:
- PDUFA VI Meeting - FY2021
- PDUFA VI Public Meeting Agenda 2021
- 2021 Public Meeting on Electronic Submissions and Data Standards Presentation
- PDUFA VI Meeting -- FY2021 *The meeting begins at the 42nd minute mark in the recording*
- PDUFA VI Meeting - FY2020: Due to the circumstances surrounding the coronavirus pandemic, the 2020 PDUFA VI Electronic Submissions and Data Standards public meeting has been cancelled.
- PDUFA VI Meeting - FY 2019
- 2019 Public Meeting on Electronic Submissions and Data Standards Presentation (PDF - 3.7MB)
- PDUFA VI Meeting – FY 2018
- 2018 Public Meeting on Electronic Submissions and Data Standards Presentation (PDF - 3 MB)
Persons with disabilities having problems accessing the PDF file(s) above may call (301) 796-3634 for assistance.
Electronic Submissions Performance Metrics
Historic and current metrics on ESG performance in relation to published targets, characterizations and volume of submissions, and standards adoption and conformance.
Collaborate with Standards Development Organizations and stakeholders to ensure long-term sustainability of supported data standards.