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Regulatory Review Support

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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This contract involves providing specialized orientation and training to regulatory reviewers within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. The focus is on equipping these reviewers with the necessary skills and knowledge to effectively use tailored tools, systems, and services that have been developed collaboratively with review offices to enhance the drug review process. The aim is to ensure that regulatory reviewers are proficient in using these customized resources to support their work efficiently. The opportunity falls under NAICS code 541990 and is categorized as a forecast, indicating a potential upcoming contract rather than an active solicitation. The contract will be administered by the FDA, specifically under the CDER Acquisitions team. Specific details regarding the place of performance and contracting officer are yet to be determined, but points of contact are provided for program inquiries. This effort highlights the FDA’s commitment to strengthening its regulatory review capabilities through specialized training and support services.

General Info

Provide specialized training for FDA CDER regulatory reviewers using customized tools and systems.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541990 - All Other Professional, Scientific, and Technical 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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Provides orientation and instruction to CDER regulatory reviewers in CDER in the use of specialized/customized tools, systems, and services that are collaboratively with review offices to support the review process.

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