God Of Gateways: Will FDA's Massive Janus Database Drive Review Efficiency Or Comparative Effectiveness Research?
The Food and Drug Administration is laying the groundwork to build a massive database that one day may provide reviewers and in-house researchers with instant access to data collected from all clinical trials for new drugs and devices ever submitted to the agency
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Taha Kass-Hout has begun his tenure as Chief Informatics Officer, focusing on scientific computing; the agency expects to hire a Chief Information Officer within 60 to 90 days to handle software development and deployment and infrastructure.
GAO finds many FDA IT initiatives stuck mid-stage in confusion. The report, prepared at the request of House Oversight Committee Chairman Darrell Issa, urges the agency to develop a better tracking and assessment system.
The May 20 meeting follows a recent reorganization of the safety functions in the Center for Drug Evaluation and Research.