FDA to upgrade reporting system for drug reactions

FDA to upgrade reporting system for drug reactions

The Food and Drug Administration seeks industry information about how to build a more comprehensive version of its Adverse Event Reporting System. The current system is a complex application used by FDA safety evaluators to monitor the safety of prescription drugs once they’re on the market. The system tracks negative reactions, illness and death as a result of drugs.

FDA, an agency of the Health and Human Services Department, posted the request for information yesterday on the FedBizOpps Web site.

Web-based applications and service-oriented architectures will allow greater flexibility, the capability to interface automatically with FDA’s MedWatch Online and other FDA applications, as well as with systems outside of FDA, and support for multiple product and terminology dictionaries. MedWatch is FDA’s gateway to safety information about the drugs and medical products that it regulates. The new reporting system must support current and emerging electronic medical record transmission and content standards.

The current system is a client-server application consisting of Oracle Forms and Reports software on the clients and Oracle relational database management system residing on a dedicated server. The database contains 264 tables and nearly 3 million adverse event reports, supports more than 200 users and handles real-time data capture and searches.

FDA would like the new reporting system to integrate its electronic submissions application and data mart and to support direct submissions from MedWatch Online.

Industry responses to FDA are due March 3.

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