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  1. FDA-TRACK: Agency-wide Program Performance

After review of the requirements set forth in the law, the agency developed a comprehensive 3-year implementation plan, balancing high priority items with available resources to provide good faith estimates of completion dates for each item. Each task includes the targeted completion date and links to contacts and additional information.

User Fee Commitment Letter deliverables are identified using the following Section numbers: PDUFA - 100; MDUFA - 200; GDUFA - 300; BSUFA - 400.

FDA will communicate its progress towards accomplishing the requirements of the FDA Safety and Innovation Act (FDASIA) by updating the chart below on a regular basis.

Download FDASIA-TRACK Dataset

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons.


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