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CDISC Membership

Active
Federal

Contract Overview

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

AI Contract Overview

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The Food and Drug Administration is renewing its annual membership in CDISC, the foundational data standard critical to its clinical and non-clinical regulatory reviews. This membership ensures the FDA remains at the forefront of global regulatory innovation by actively participating in the development and refinement of industry-wide data standards. Without CDISC, the agency would be unable to modernize its review processes effectively, compromising efficiency, consistency, and interoperability in evaluating medical products. The cost of renewal is minimal relative to the strategic value it delivers, enabling the FDA to maintain leadership in shaping global regulatory data practices. The opportunity is forecasted for posting on May 25, 2026, under NAICS code 813920, and is managed by the FDA's Center for Drug Evaluation and Research. The primary point of contact for program inquiries is cderacquisitions@fda.hhs.gov, while the contracting officer position is currently pending assignment. There is no set-aside classification specified, and the place of performance is not defined, indicating that this is a non-location-specific organizational membership rather than a service contract with physical deliverables. The continued investment in CDISC membership supports the FDA’s mission to uphold the highest standards of data integrity and regulatory science worldwide.

General Info

FDA renews CDISC membership to maintain and advance clinical data standards globally.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

813920 - Professional OrganizationsView NAICS

Place of Performance

US

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

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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The CDISC standard serves as the foundational data standard for FDA's daily operations in conducting clinical and non-clinical reviews. Our continued participation in CDISC discussions and standard development ensures that FDA maintains its position as the leading global regulatory health authority in establishing critical data standards. Without proper data standards like CDISC, FDA cannot effectively modernize the regulatory review process. The annual membership renewal cost ( per year) represents a minimal investment that enables FDA to exercise leadership in the global regulatory review arena.

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