*GDUFA IV Implementations Reporting and Analytics
Type: Forecast
Overview
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 reporting and analytics related platforms.
Est. Value
Min: $1,500,000
Max: $3,000,000
Max: $3,000,000
Est. Award Date
27-Jan
Future Opp
Source Est. Solicitation Date
26-Jul
Set Aside
To be determined
Place of Performance
USA
Forecast Source
Department of Health and Human Services
Food and Drug Administration is forecasted to issue a procurement for *GDUFA IV Implementations Reporting and Analytics around 27-Jan worth up to $3,000,000.
Agency
Source Level 1 Agency
Department of Health and Human Services
Source Level 2 Agency
FDA
Contacts
Potential Bidders and Partners
Similar Active Opportunities
Additional Detail
Date Published
11/6/26
Date Modified
11/7/26
Additional Notes
Program Office: 75F401; Contracting Office: 75F402