*GDUFA IV Implementations Portal
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 the Generic Drug User Fee Amendments IV (GDUFA IV) reauthorization, which becomes effective October 1, 2027, with solicitation release estimated for July 1, 2026 and award targeted for January 1, 2027. The contract covers system-level enhancements to generic drug workflows, reporting, and data management across CDER regulatory systems, including the CDER NextGen Portal and legacy platforms such as DARRTS and Panorama, to support new or updated commitments introduced through the GDUFA IV commitment letter.
The estimated award value ranges from $3 million to $7 million. Performance location and specific technical requirements are not specified. Questions may 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 CDER NextGen Portal and legacy systems including DARRTS, Panorama, and other related platforms.
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