Simplifying the Drug Application Management for CDER

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Overview

The Center for Drug Evaluation and Research (CDER) is tasked with tracking, reporting, and maintaining records related to drug and biological product applications. These records are used for reporting to Congress on various performance goals under the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BSUFA), and other regulations. CDER’s previous tracking and archiving systems were outdated, leading to the creation of the Document Archiving, Reporting, and Regulatory Tracking System (DARRTS), a multi-tier, web-based enterprise application designed to streamline application submissions, document archiving, and report generation.

Goal

The primary goal of DARRTS is to consolidate multiple functions into one system, enabling CDER to efficiently manage, track, and archive application submissions while generating standardized documents during the application review process. The system also supports reporting to Congress, ensuring compliance with PDUFA, BSUFA, and GDUFA (Generic Drug User Fee Act) goals.

Challenge

CDER’s legacy systems were technically outdated and could not accommodate evolving business practices. Integrating the functionality of various legacy applications into a single, flexible, and scalable system was a complex challenge. Additionally, CDER required enhancements to support new application types and streamline application review processes across a large user base of over 4,000 CDER staff.

Solution

Sky Solutions implemented a modernized solution for CDER by performing critical operations and maintenance, leading development and testing for new change requests, and deploying continuous integration and delivery (CICD) pipelines using Jenkins and Git. Sky developed REST web services utilizing existing Oracle Application Development Framework (ADF) models, enabling seamless integration for future modernization efforts. By adopting an Agile Development Life Cycle (ADLC) methodology with Scrum practices, Sky ensured transparency, collaboration, and iterative progress.

Sky Solutions led the effort in the following areas:

  • Conducted operations and maintenance for the DARRTS application.
  • Handled development, testing, and release management for both defects and new change requests.
  • Developed REST web services to modernize CDER’s architecture using the existing ADF model.
  • Supported technical and functional integrations, along with feasibility assessments for new modernization initiatives.
  • Leveraged the Oracle ADF tech stack on WebLogic, Oracle DB on-premises, and REST web services.

Technologies/Methodologies

  • Oracle ADF (Application Development Framework): Used for developing the application's business components and UI following the MVC pattern.
  • Oracle Fusion Middleware (WebLogic, OHS): Provides the application server environment for running the DARRTS application.
  • Oracle DB (On-Premises): The primary database for storing and managing the application data.
  • REST Web Services: Implemented using the existing Oracle ADF Model for integration and modernization efforts.
  • Jenkins:(CI/CD) pipelines.
  • Git Hub.

Outcome

The DARRTS system was significantly enhanced, providing a more flexible and scalable platform for managing drug applications. By replacing manual deployments with automated CI/CD pipelines, Sky streamlined the release process, reduced downtime, and improved overall system performance. The integration of REST web services using the ADF model allowed CDER to modernize its application architecture while maintaining acceptable response times. As a result, the FDA was better equipped to track, report, and archive submissions, improving their ability to meet Congressional reporting requirements and enhancing operational efficiency across the board.

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