*Regulatory Review Modernization Development (OGD Structured Reviews - GDSA) Ne

The Generic Drug Structured Assessment (GDSA) Program is an OGD-wide initiative managed by FDA's Office of Digital Transformation (ODT) that delivers structured, knowledge-managed regulatory review workflows for the Office of Generic Drugs (OGD) within CDER. GDSA modernizes OGD's review processes across three active use cases - Bioequivalence (BE), Labeling Review (LRT), and Clinical Review (CRT) - by transitioning reviewers from manual, narrative-based assessments to automated structured reviews within CDER Nexus (Appian). The program leverages a common platform foundation (Nexus/Appian, CDEROne, OneNexus, Halo, and AI tools/technologies) to deliver consistent structured assessment capabilities across OGD's three primary review disciplines, enabling knowledge management, cross-review analytics, and enterprise reporting. GDSA integrates with FDA enterprise systems including CDEROne, OneNexus, Halo, EDR, and Panorama to auto-populate review data, generate reports and dashboards, and maintain an enterprise data hub for historical and future structured reviews. The GDSA Program DME scope for FY27 includes: (1) expansion of GDSA-BE structured review templates across additional dosage forms and study designs, with migration from current FISMA High to Appian managed FedRAMP High; (2) enhancement of GDSA-LRT with new capabilities including GDUFA IV redlining, carton/container comparison, AI-enabled labeling intelligence, and Microsoft 365 integration; and (3) new development of GDSA-CRT for OGD's Division of Clinical Review, including Comparative Analysis templates, Physical Comparison tables, and Maximum Daily Dose estimation reviews. Across all use cases, AI tools/technologies and Halo integration are being leveraged for intelligent data auto-population, analytics, and AI-prompt-driven search of the GDSA enterprise data repository.