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

Active
Federal

Contract Overview

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

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The contract supports the continued development and maintenance of two critical systems used by the Food and Drug Administration’s Center for Drug Evaluation and Research: the Knowledge-aided Assessment and Structured Application (KASA) system and the Office of Generic Drugs Label Review Tool (LRT). For KASA, fiscal year 2022 enhancements focus on expanding functionality through the addition of the Drug Substance module, ATL summary capabilities, ANDA Liquid Dosage assessments, and Integrated Assessment workflows. The LRT serves as a unified platform that consolidates diverse data sources into a single interface, enabling reviewers to perform labeling assessments using the standard OGD review template. The work also involves maintaining the newly deployed Appian-based infrastructure and adding new features such as enhanced workflows, system integrations, and improved reporting tools to increase efficiency and accuracy in regulatory reviews. The contract structure includes base performance years with optional recurring periods to ensure sustained support and evolution of these systems.

General Info

Develop and maintain KASA system and OGD Label Review Tool for enhanced FDA regulatory review.

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

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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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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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