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*GDUFA IV Implementations Workflow

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 project for GDUFA IV Implementations Workflow to support the reauthorization of the Generic Drug User Fee Amendments IV, which is expected to take effect on October 1, 2027. This initiative focuses on enhancing generic drug workflows, reporting, and data management to meet new or updated commitments outlined in the GDUFA IV commitment letter. The scope of work involves implementing system-level changes across several CDER regulatory platforms, including OneNexus, CDER Nexus, KASA, and OGD Structured Review. This effort ensures that the agency's digital infrastructure is aligned with updated regulatory requirements for the processing and oversight of generic drugs.

General Info

FDA project to update generic drug workflows and systems for GDUFA IV reauthorization.

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 OneNexus, CDER Nexus, KASA, OGD Structured Review and other related platforms.

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