FDA CDER Drug Compliance
Investment ID: 009-000318788
Overview
Program Title
FDA CDER Drug Compliance
Description
This investment allows CDER to align the IT initiatives with existing business solutions and service lines as described by the Office of Business Informatics and supported by the Executive Committee.
Type of Program
Non-major IT Investments
Multi-Agency Category
Not Applicable
Investment Detail
The investment is aimed at enabling the FDA to track inventory data with an integrated process flow. The investment provides several qualitative benefits to public health, the industry and the FDA.
In an effort to enhance the operational efficiency of various CDER lines of business (LOBs) and the IT systems that are in place to support them, it is imperative for CDER to develop an integrated approach to collect, maintain, and report the underlying regulatory data. This approach will be used to establish a single source of truth for a given type of business data domain that spans from investigational to approval and to post-market surveillance. Applying cross-cutting processes requires the integration and management of existing business processes in the areas of product quality, approved drug publishing, regulatory review, and user fee management.
Consolidated from the historic unstructured data to the electronic submitted structured data, the Drug Compliance investment will provide an authoritative, single source platform for tracking inventory data to improve the efficiency, reliability, and uniformity of the regulatory processes that ensures quality across the Agency.
- Improved Productivity
With an automated approach, the investment reduces the cost of processing new applications and at the same time ensures that the reviewers can work with greater efficiency. This results in enhancing FDA's ability to optimize the costs through performing more work without a corresponding increase in overhead. The satisfaction of the employees involved is improved contributing to greater retention of valuable skillsets, enabling the FDA to serve the needs of the public and industry effectively.
An alternatives analysis was developed to determine the most feasible way to provide the benefits listed above. This has been uploaded to the PMT and provided to the CPIC team.
In an effort to enhance the operational efficiency of various CDER lines of business (LOBs) and the IT systems that are in place to support them, it is imperative for CDER to develop an integrated approach to collect, maintain, and report the underlying regulatory data. This approach will be used to establish a single source of truth for a given type of business data domain that spans from investigational to approval and to post-market surveillance. Applying cross-cutting processes requires the integration and management of existing business processes in the areas of product quality, approved drug publishing, regulatory review, and user fee management.
Consolidated from the historic unstructured data to the electronic submitted structured data, the Drug Compliance investment will provide an authoritative, single source platform for tracking inventory data to improve the efficiency, reliability, and uniformity of the regulatory processes that ensures quality across the Agency.
- Improved Productivity
With an automated approach, the investment reduces the cost of processing new applications and at the same time ensures that the reviewers can work with greater efficiency. This results in enhancing FDA's ability to optimize the costs through performing more work without a corresponding increase in overhead. The satisfaction of the employees involved is improved contributing to greater retention of valuable skillsets, enabling the FDA to serve the needs of the public and industry effectively.
An alternatives analysis was developed to determine the most feasible way to provide the benefits listed above. This has been uploaded to the PMT and provided to the CPIC team.