FDA Requests $400M to Transform Operational and Regulatory Processes

By Daniel R. Matlis

One of the last remaining perks of a transcontinental flight is the ability to put on a set of noise cancelling headsets, listen to your favorite tunes and read through a hefty 600 plus page volume. I chose the 604 page Fiscal Year 2011 Food and Drug Administration Justification of Estimates for Appropriations Committees.

As I ploughed through this “engaging material”, I noticed that FDA’s 2011 Budget Justification includes a 400 Million Dollar investment in information technology (IT). Through this funding, FDA will continue to expand the adoption of Agency-wide systems supporting the transformation of nearly every aspect of Agency operations and regulatory duties.

The budget justification identified the following Agency-wide systems for use by ALL FDA centers and offices:

Regulated Product Submission (RPS) will provide a standard framework for receiving regulatory information using predefined parameters for the more efficient identification and cataloging of submitted information.

Janus will establish FDA-wide data architecture and standards that will ultimately convert and store scientific data from external and internal sources into a structured format that can be used throughout FDA.

The Common Electronic Document Room (cEDR) will establish a single, FDA-wide repository for all FDA-regulated documents and provide an end-to-end electronic environment from the receipt of product pre-market application information through its review, approval, and post-market surveillance to achieve a more efficient review and surveillance process.

Harmonized Inventory (HI) will provide a complete and reliable inventory of firms, facilities, products, and components/ingredients, as well as their relationships and points of contact for all FDA regulated products.

MedWatch Plus will provide an integrated system for receiving, processing, storing and analyzing adverse event reports and other safety information for all FDA regulated products.

FDA Advisory Committee Tracking and Reporting System (FACTRS) will provide a fully electronic system to support advisory committee meetings and management of meeting information, people, and reporting capabilities.

 As we revealed in Axendia’s “FDA e-Transformation” whitepaper, the agency is implementing 21st century IT systems and infrastructure. This modernization will create a robust foundation to enable interoperability of regulatory data and support information sharing across the FDA centers and program areas. Shared systems will support agency-wide activities ranging from pre-market review for all regulated products to post-market surveillance, including adverse event detection and future scientific computing capabilities.

Are you ready for the 21st Century FDA?

To schedule a briefing detailing our findings and analysis on this topic, please contact Axendia at info@axendia.com
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