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Diane Publishing Books
Information Technology: FDA Needs to Fully Implement Key Management Practices to Lessen Modernization Risks
Valerie C. Melvin (au)
The Food and Drug Admin. (FDA), an agency within the Dept. of Health and Human Services (HHS), relies heavily on information technology (IT) to carry out its mission of ensuring the safety and effectiveness of regulated consumer products. Specifically, IT systems are critical to FDAäó»s product review, adverse event reporting, and compliance activities. Recognizing limitations in its IT capabilities, the agency has undertaken various initiatives to modernize its systems. This report (1) assesses FDAäó»s current portfolio of IT systems, including the number of systems in use and under development, and their purpose and costs; (2) assesses the status and effectiveness of FDA's efforts to modernize the mission-critical systems that support its regulatory programs; and (3) examines the agency's progress in effectively integrating and sharing data among key systems. Tables and figures. This is a print on demand report.
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