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*GDUFA IV Implementations Workflow
Department of Health and Human Services.Food and Drug Administration.75F401.75F402
- Est. solicitation
- Jul 1, 2026
- Date posted
- —
- Source
- Open forecast
Description
The Generic Drug User Fee Amendments IV (GDUFA IV) reauthorization, expected to become effective on October 1, 2027, will require enhancements to generic drug workflows, reporting, and data management across multiple CDER regulatory systems. This contract is to implement any new or updated commitments introduced through the GDUFA IV commitment letter may necessitate system-level changes to OneNexus, CDER Nexus, KASA, OGD Structured Review and other related platforms.
Planning details
- Estimated value
- >= $3M and < $7M
- Est. solicitation date
- Jul 1, 2026
- Anticipated award
- Jan 1, 2027