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

Department of Health and Human Services.Food and Drug Administration.75F401
Est. solicitation
Jan 1, 2026
Date posted

Description

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)

Planning details

Estimated value
>= $7M and < $13M
Est. solicitation date
Jan 1, 2026
Anticipated award
Jun 1, 2026

Classifications

  • NAICS541519
  • PSC541519

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