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PDUFA VII Information Technology and Bioinformatics Goals and Progress

Enhancing Transparency and Leveraging Modern Technology

FDA will engage industry to provide feedback and/or participate in pilot testing in advance of implementing significant changes that impact industry's interaction with the enterprise-wide systems.

Maintain a current FDA Data Standards Catalog and Data Standards Action Plan

Develop Data and Technology Modernization Strategy

FDA will progress a Data and Technology Modernization Strategy (“Strategy”) that provides FDA’s strategic direction for current and future state data-driven regulatory initiatives.

Promote Convergence

  • FDA will continue to engage with stakeholders and international consortia (e.g., ICH, ICMRA) on technology and innovation initiatives that promote convergence in data interoperability and interpretability for current and future FDA initiatives throughout the regulatory lifecycle.
  • FDA will seek to adopt international standards where feasible and appropriate, giving considerations to cybersecurity risk, international commitments, legal constraints, and other relevant factors.

Accelerate CBER Modernization

Annually and at key milestones, CBER will share its roadmap, provide updates on its progress including successes, issues, performance metrics, accomplishments and any issues or necessary adjustments to accommodate unexpected events (e.g., contracting, delays outside of CBER control) or reasonable deviations from its modernization roadmap. This information will be shared at regularly scheduled FDA-Industry meetings.

  • CBER Modernization Roadmap
    • Discussed with industry at regularly scheduled PDUFA VII meetings

Monitor and Modernize ESG

FDA will continue to ensure the usability and improvement of the ESG.

Annually, FDA will provide on the ESG website historic and current metrics on ESG performance in relation to published targets, characterizations and volume of submissions, and standards adoption and conformance.

  • Published ESG target timeframes, characterizations, and volume
  • Historic and current metrics on ESG performance
  • FDA will advance the ESG cloud-based modernization with an improved architecture that supports greatly expanding data submission bandwidth and storage, while continuing to ensure its stable operation.

Leverage Cloud Technology to Progress Regulatory Digital Transformation

By the end of Q3 FY 2023, FDA will assess challenges or barriers in FDA's adoption of cloud-based technologies in applicant-regulator interactions and within 6 months will publish the findings of this assessment. FDA teamed with Eagle Consulting (EHC), a third-party contractor, to conduct this assessment.

Below is the EHC assessment report along with FDA’s management response.

In FY 2023, FDA, in consultation with industry, will prioritize and initiate the first of at least 3 demonstration projects to explore application of cloud-based technologies to streamline, improve and enable a variety of applicant-regulator interactions.

Provide Bioinformatics IT Support

FDA will assess its bioinformatics capabilities, and annually, ensure that IT resources are provided to support bioinformatics activities, including software licensing, cloud-based storage and computing capacity, operations support and maintenance.

Expanding and Enhancing Bioinformatics Support

Bioinformatics and computational biology are increasingly being used to assess product quality, safety and efficacy and facilitate the development, characterization and manufacture of human drugs and biologics.

FDA will continue to develop data standards and revise guidance or issue draft guidance on this topic including how to submit, and format submissions, and technical validation criteria. FDA will work globally to advance harmonization of these standards and methodologies.

Digital Health Technologies (DHTs) for Drug Development and Review

PDUFA VII has outlined several activities related to DHTs for drug development and review. For more information, refer to Digital Health Technologies (DHTs) for Drug Development | FDA.

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