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The Future of the FDA: Operating in an 'Electronic World'

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White Paper 1 The Future of the FDA: Operating in an "Electronic World" Introduction Historically, interactions between the FDA and the companies it regulates have involved the creation, printing and delivery of volumes of paper documents. These documents may have been delivered as part of an application, or reviewed onsite, in the course of an inspection. Over the past few years, the FDA and the industries it regulates have recognized the need for a modern, well-integrated, reliable, efficient and affordable electronic information infrastructure to support FDA administrative, regulatory and business operations. To achieve this transformational goal, the agency has embarked on a series of organizational and information technology activities. These activities are aimed at advancing ongoing electronic communications inside the agency, with the public and between the FDA the companies it regulates. This whitepaper discusses FDA transformational activities that promise to usher in a new era of electronic interactions between the agency and its constituents, and is based on primary research conducted by Axendia Inc. and commissioned by MasterControl. Research Approach The research by Axendia Inc. identified key organizational and technology initiatives the FDA is undertaking to advance ongoing electronic communication and interactions. The research was based on one-on-one interviews with FDA officials and other FDA sources, as well as on publicly available information. Bioinformatics Board According to Dr. Armando Oliva, FDA Deputy Director for Bioinformatics, "It's fair to say that the [FDA] is actively moving toward an electronic world where all regulated product information comes in electronically. I couldn't tell you when that is going to happen, but certainly there are active discussions underway to move to an 'all electronic submission environment' for all FDA regulated product information, whether it be product quality, manufacturing, pre-market, or post market data." The Bioinformatics Board (BiB) is at the center of the agency's e-transformation. In February 2006, the FDA's senior management approved the formation of the Bioinformatics Board (See Figure 1: FDA Bioinformatics Board organizational chart), and charged it with overseeing the planning and control of bioinformatics activities, as well as ensuring that these activities are communicated throughout all levels of the agency. "It's fair to say that the [FDA] is actively moving toward an electronic world where all regulated product information comes in electronically. I couldn't tell you when that is going to happen, but certainly there are active discussions underway to move to an 'all electronic submission environment' for all FDA regulated product information..." Dr. Armando Oliva FDA Deputy Director for Bioinformatics, FDA

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