*GDUFA IV Implementations Reporting and Analytics
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- 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) reporting and analytics enhancements, with an estimated solicitation release on July 1, 2026 and award on January 1, 2027. The contract will address system-level changes to reporting and analytics platforms across multiple CDER regulatory systems to support new or updated commitments introduced through the GDUFA IV commitment letter, with the reauthorization expected to become effective October 1, 2027.
The estimated award value ranges from $1.5 million to $3 million. Points of contact are available through the FDA Acquisition Liaison mailbox 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 reporting and analytics related platforms.
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