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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It Takes Two: FDA Reorganizes Office Of Information Management
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.
FDA’s Janus Database Among Projects Stuck In Agency’s IT Quagmire
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.
FDA's Science Board To Review Comparative Effectiveness, Pharmacovigilance, Nanotech
The May 20 meeting follows a recent reorganization of the safety functions in the Center for Drug Evaluation and Research.