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*Structured Review KASA New Contract

Forecast

Federal

Contract Overview

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AI Contract Overview

The Food and Drug Administration is seeking to implement enhancements to the Knowledge-Aided Assessment and Structure Application known as KASA. This tool is designed to streamline the application review process by utilizing pre-populated templates and risk identification algorithms to reduce manual narratives and administrative burdens. The primary objective is to transition toward a more structured review environment that increases efficiency across various application types, including ANDA, NDA, BLA, DMF, and Facilities reviews. Key technical goals include the integration of KASA with the OneNexus platform to create a unified regulatory ecosystem and the incorporation of AI tools such as Elsa and Google Gemini to automate data entry and response generation. The project will also focus on developing quality assessment modules for drug products and manufacturing, automating deficiency communications, and implementing advanced data visualization and analytics capabilities for scientific data and stakeholder reporting.

General Info

FDA seeks KASA enhancements using AI and OneNexus to streamline regulatory application reviews.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541519 - Other Computer Related Services

Place of Performance

USA

Set-Aside

NONE

Documents

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Organization & Contact Information

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

OPQ's Knowledge -Aided Assessment and Structure Application (KASA) is a tool developed for the reviews focused on making the application review more structured and efficient. Assessment templates are pre-populated with data, algorithms for risk identifications, mitigation and communications all in a structure format, while minimizing the text-based narratives, administrative task and summaries of information. KASA enhancements plan new features to support NDA and BLA quality structured review assessments and to facilitate integration with OneNexus and AI-assisted review.-OneNexus Platform Integration: Integrate KASA with OneNexus for Facilities, DMF, and all marketing applications to create a unified regulatory ecosystem. -AI Workstream/Intelligent Review Automation: Integrate FDA AI tools (including Elsa, Google Gemini, etc.) building workflows enabling auto-populating AI responses within the structured review system, reducing manual data entry and improving review efficiency for ANDA, NDA, DMF, Facilities, etc. -Quality Assessment Module Development: Leverage current ANDA modules to create comprehensive NDA quality assessment modules covering drug products, manufacturing processes, facilities, microbiology, and biopharmaceutics. -Deficiency Management and Communication: Automate compilation and communication of KASA assessment deficiencies through OneNexus.- Advanced Data Visualization and Communication: Implement visualizations for scientific data within OneNexus with drill-down capabilities and coordinated communication to industry stakeholders. -Comprehensive Reporting and Analytics Capabilities: Develop intuitive end-user reports and analytics views within the application.