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. |