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FDA and NIH Seek Information on Establishing an Electronic Platform
Comments due end of April

The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are seeking information from interested parties on the formation of a public-private partnership whose goal it would be to establish and maintain a common electronic platform (e-platform) for the exchange of clinical research data (i.e., the data normally collected during the course of a clinical trial), as well as the submission, receipt, and management of regulatory product information. Such a platform for managing data gathered on medical products all along the regulatory product information supply chain would make use of available bioinformatics technology to systematize the exchange of medical product information beginning in the earliest stage of clinical research through approval to postmarket surveillance, greatly enhancing the efficiency of exchanging medical product information among all interested parties. Such an effort would also be a big step toward the fulfillment of the President's National health IT effort, one goal of which is to make medical products safer and more effective than ever before. More Information

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