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U.S. Food and Drug Administration
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DIDR Information Warehouse

The Demographic Information and Data Repository projects (DIDR) are a set of Agency-wide projects proposed in response to a Congressional mandate to develop a database focused on women's health activities. The Agency-wide data repository will hold information on product safety and efficacy. Clinical study data, review documents and labeling are the first elements targeted for inclusion in the repository. This triad of DIDR projects, study data, labeling and reviews, will provide the basis for development of a comprehensive institutional knowledge-base focused upon process improvements. These improvements will enhance consistency in submissions to the agency and will achieve identified objectives in the FDA's Performance Plans.

DIDR projects are directed at upgrading and modernizing the FDA's information management infrastructure Agency-wide related to health and regulatory information to help improve regulatory decision-making and enhance risk management of medical products for sub-populations. Additionally, the projects will improve the delivery of services to consumers and industry through the adoption of Agency-wide standards for data and dissemination of data to consumers.

The Labeling Warehouse System (LWS) is the first DIDR project selected for implementation. The LWS will re-engineer business processes to become more fully integrated with available technology, reducing the burden and enhancing the efficiency of label submission for reviewers and industry. In addition, the LWS will provide more timely and accurate label information to health care providers and consumers, reducing risks associated with the use of medical products. Finally, the LWS will provide an agency-wide resource for the content of labeling. Significant progress to the LWS was made in FY03.

rule Office of Women's Healthlink to FDA home pagelink to U.S. Department of Health and Human ServicesFDA logo--link to FDA home page