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

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The Generic Drug Structured Assessment Program is an FDA initiative managed by the Office of Digital Transformation to modernize regulatory review workflows for the Office of Generic Drugs. By transitioning from manual narrative assessments to automated structured reviews within the CDER Nexus Appian platform, the program enhances consistency and knowledge management across Bioequivalence, Labeling Review, and Clinical Review disciplines. The system integrates with various enterprise tools, including CDEROne, OneNexus, and Halo, to enable data auto-population, cross-review analytics, and comprehensive enterprise reporting. For fiscal year 2027, the scope of work focuses on expanding structured review templates for various dosage forms and migrating to a FedRAMP High environment. Key enhancements include the integration of AI-enabled labeling intelligence and Microsoft 365 for labeling reviews, as well as the new development of clinical review capabilities such as Comparative Analysis templates and Maximum Daily Dose estimation. The program continues to leverage AI technologies and Halo integration to provide intelligent data population and prompt-driven searches within the enterprise data repository.

General Info

FDA program modernizing generic drug reviews via automation, AI, and structured Appian workflows.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541512 - Computer Systems Design Services

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Organization / AgencyFood and Drug Administration → Food And Drug Administration
Office AddressN/A
Contacts
Cder Acquisition Liaison
contact@example.gov
To Be Determined To Be DeterminedContracting Officer

Full Description

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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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