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*GDUFA IV Implementations Reporting and Analytics

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 GDUFA IV Implementations Reporting and Analytics to support the reauthorization of the Generic Drug User Fee Amendments IV. 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. The scope of work involves implementing new or updated commitments outlined in the GDUFA IV commitment letter, which may require significant system-level modifications to reporting and analytics platforms. This effort is categorized under NAICS code 541990 and is managed by the FDA's CDER acquisitions team.

General Info

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

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541990 - All Other Professional, Scientific, and Technical 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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Timeline

PostedJan 1

forecast

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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 reporting and analytics related platforms.

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