Modernizing FDA’s Drug Review Processes for Transparency and Efficiency

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Overview

The FDA’s Center for Drug Evaluation and Research (CDER) sought to replace its legacy systems, DARRTS and Panorama, with a unified, scalable platform to enhance transparency, streamline drug review processes, and harmonize operations. Sky Solutions developed a Proof of Concept (POC) for the OneNexus platform using Appian on AWS GovCloud, improving data transparency for over 1,500 users, simplifying workflows, and reducing risks from outdated systems, paving the way for future innovation.

Goal

The primary goal was to develop a modern, unified platform to enhance CDER’s drug evaluation processes, improve data transparency for over 1,500 users, and streamline workflows across the drug lifecycle. Additionally, the solution aimed to reduce operational risks associated with legacy systems, harmonize business processes across offices, and provide a scalable foundation for future innovation in drug application and regulatory review.

Challenge

The U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is responsible for ensuring the safety and efficacy of drugs available in the United States. To enhance data transparency, streamline management, and improve reporting, CDER sought to modernize its drug review process across the drug lifecycle and harmonize business processes across various offices. To achieve this, CDER aimed to replace its legacy systems—such as DARRTS and Panorama—with a unified, scalable platform. The Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) is a platform for CDER to manage, track, and report drug applications, while Panorama automates FDA review and project management tasks. A key challenge in transitioning from these legacy systems was ensuring the new platform could handle complex workflows and meet the diverse needs of CDER offices.

Solutions

Sky Solutions designed and developed a Proof of Concept (POC) for CDER’s OneNexus platform to validate system functionality and establish a foundation for future development. Using Appian on AWS GovCloud, Sky Solutions created the POC to demonstrate core functionality for NDA and ANDA application review. They also built a reusable workflow framework, managed user access, and established clear deployment guidelines. To address the challenge of atomic transactions, Sky Solutions utilized database stored procedures for transactional writes, while Appian handled the business logic.

Technologies Used

  • Appian on GovCloud: Development platform for OneNexus
  • Oracle DB on Premises: Database solution
  • Microsoft SharePoint on Azure: Document collaboration tool
  • Atlassian Jira & Confluence: Agile project management tools
  • CDEROne Analytics: Integration for drug product details

Outcome

Sky Solutions delivered the POC, earning positive feedback from CDER leadership and advancing the OneNexus project. Key outcomes include:
  • Improved data transparency for 1,500+ users
  • Streamlined drug evaluation processes
  • Reduced risks from decommissioning legacy systems
  • Harmonized processes and operational issues across CDER offices
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