*GDUFA IV Implementations Workflow
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring implementation services for Generic Drug User Fee Amendments IV (GDUFA IV) workflow enhancements across multiple Center for Drug Evaluation and Research regulatory systems, with an estimated solicitation release date of July 1, 2026, and estimated award date of January 1, 2027. The contract will address system-level changes required by GDUFA IV reauthorization commitments effective October 1, 2027, affecting OneNexus, CDER Nexus, KASA, OGD Structured Review, and related platforms.
The estimated award value ranges from $3 million to $7 million. Inquiries should be directed to the FDA's Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
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.
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