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Intake and Data Exchange (CDER Event Data Management 8.0)

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 the expansion of its Event Data Management capability under the Intake and Data Exchange (CDER Event Data Management 8.0) initiative to support additional use cases and deliver a more integrated submissions and data management solution. This effort aims to enhance the existing system by broadening its functionality to accommodate broader data exchange needs across regulatory operations, improving efficiency and coordination in handling event-related information. The project is aligned with NAICS code 541519, indicating it involves other scientific and technical consulting services, and is intended to modernize and scale the current infrastructure to meet evolving regulatory data demands. The opportunity is currently in the forecasting phase with a posted date of May 25, 2026, and no solicitation number assigned yet. The point of contact for program inquiries is the Cder Acquisition Liaison at cderacquisitions@fda.hhs.gov, while the contracting officer role remains to be determined. There is no specific place of performance or set-aside type indicated, and no details are provided regarding geographic restrictions or small business preferences. Potential vendors should prepare for a future full solicitation that will likely require proven experience in managing complex regulatory data systems and delivering scalable, integrated solutions for government health agencies.

General Info

Extending FDA CDER Event Data Management 8.0 for improved submission and data integration.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541519 - Other Computer Related ServicesView NAICS

Place of Performance

US

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedMay 25

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 / Agency

Food 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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Extend and expand the established Event Data Management capability to support additional use cases in order to provide integrated submissions and data management solution.

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