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Regulatory Review Modernization Development (KASA & OGD Label Tool, Struct Rev

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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 seeking development and maintenance services for the Knowledge-aided Assessment and Structured Application system and the OGD Label Review Tool. The project focuses on enhancing the KASA system through the addition of the Drug Substance module, ATL summary, ANDA Liquid Dosage, and Integrated Assessment. Simultaneously, the OGD Label Review Tool will be developed to integrate various data sources into a user interface that supports labeling assessments based on current review templates. Technical requirements include the maintenance of a new Appian deployment and the implementation of new workflows, integrations, and reporting capabilities. This effort is structured as a base contract with recurring option years. The project falls under NAICS code 541519 and is managed by the Food and Drug Administration.

General Info

FDA seeks development and maintenance services for KASA and OGD Label Review tools.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541519 - Other Computer Related Services

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents 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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Regulatory Review Modernization Development (KASA & OGD Label Tool, Sturctured Review) This contract is for development and maintenance of Knowledge-aided Assessment and Structured Application (KASA) system and OGD's Label Review Tool (LRT). For KASA, further development in FY22 includes Drug Substance module, ATL summary, ANDA Liquid Dosage, and Integrated Assessment. The OGD Label Review Tool (LRT) brings together data sources allowing access through a user interface for labeling assessments based on current review template used by OGD for reviews. The work includes maintenance of the new Appian deployment, and new features including new workflows, integrations, and reporting capabilities. This will be base plus option years (reoccurring)

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