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

This contract involves the development and ongoing maintenance of the Knowledge-aided Assessment and Structured Application (KASA) system, alongside the Office of Generic Drugs (OGD) Label Review Tool (LRT). Enhancements planned for the KASA system in fiscal year 2022 include the addition of modules such as the Drug Substance module, ATL summary, ANDA Liquid Dosage, and Integrated Assessment to support a more comprehensive regulatory review process. The OGD Label Review Tool is designed to consolidate various data sources into an accessible user interface, facilitating labeling assessments in alignment with current OGD review templates. The scope of work extends beyond development to include sustained maintenance of the newly deployed Appian platform, focusing on enhancing workflows, integrations, and reporting features. This contract follows a base period with option years, indicating recurring work to ensure the modernization and efficiency of regulatory review tools used by the FDA. The contract falls under NAICS code 541519, which pertains to other computer related services, reflecting the technical nature of the deliverables. Communication and coordination for the contract will be managed through designated FDA acquisition personnel.