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*GDUFA IV Implementations Portal

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The Food and Drug Administration is forecasting a contract for the GDUFA IV Implementations Portal to support the Generic Drug User Fee Amendments IV reauthorization. Expected to take effect on October 1, 2027, this initiative focuses on enhancing generic drug workflows, reporting, and data management across various CDER regulatory systems to meet new or updated commitments. The scope of work involves implementing system-level changes to the CDER NextGen Portal as well as legacy platforms, including DARRTS and Panorama. This effort ensures that the agency's digital infrastructure is aligned with the regulatory requirements introduced through the GDUFA IV commitment letter.

General Info

FDA contract for GDUFA IV portal to enhance generic drug workflows and reporting.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541512 - Computer Systems Design Services

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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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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