*Structured Review KASA New Contract
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $7,000,000 to $13,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541519 Other Computer Related Services
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring enhancements and integrations to KASA (Knowledge-Aided Assessment and Structure Application), a structured review tool designed to streamline regulatory application assessments through pre-populated templates, risk algorithms, and reduced narrative documentation. The scope includes integration with the OneNexus platform, AI-assisted review automation leveraging FDA tools, development of quality assessment modules for NDA and BLA applications, and advanced data visualization and analytics capabilities. The solicitation is estimated to release January 1, 2027, with award anticipated June 1, 2027.
The estimated award value ranges from $7 million to $13 million under NAICS 541519 (Other Computer Related Services), with no set-aside applied. Work encompasses deficiency management automation, comprehensive reporting infrastructure, and integration across ANDA, NDA, DMF, and facilities modules to create a unified regulatory ecosystem. Questions should be directed to the FDA Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
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.
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