*Regulatory Review Modernization Development (OGD Structured Reviews - GDSA) Ne
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- 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 development and modernization services for the Generic Drug Structured Assessment (GDSA) Program, an Office of Generic Drugs initiative that transitions regulatory reviewers from manual narrative assessments to automated structured reviews within FDA's Nexus (Appian) platform. The work covers three active use cases—Bioequivalence, Labeling Review, and Clinical Review—and includes expansion of existing templates, enhancement of labeling capabilities with AI-enabled intelligence and Microsoft 365 integration, and new development of clinical review workflows with comparative analysis and maximum daily dose estimation features. Solicitation is estimated to release January 1, 2027, with award targeted for September 1, 2027.
The estimated award value ranges from $3 million to $7 million. The GDSA Program leverages a common platform foundation including Nexus/Appian, CDEROne, OneNexus, Halo, and AI tools integrated with FDA enterprise systems for automated data population, reporting, dashboards, and an enterprise data hub for structured reviews. Work is performed within the FDA's Center for Drug Evaluation and Research (CDER) Office of Generic Drugs and Office of Digital Transformation. Questions should be directed to the FDA Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
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.
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