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PDUFA VI Information Technology Goals and Progress

PDUFA VI Information Technology Goals and Progress

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)

ESG Target Timeframes, Milestones and Notifications

C.  ENHANCE TRANSPARENCY AND ACCOUNTABILITY OF FDA ELECTRONIC SUBMISSION AND DATA STANDARDS ACTIVITIES

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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:

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.

Data Standards

Collaborate with Standards Development Organizations and stakeholders to ensure long-term sustainability of supported data standards.

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