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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 on-site in the course of an inspection.
Over the last few years, the FDA and industry have recognised 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 organisational and information technology activities. These initiatives are aimed at advancing ongoing electronic communication and interactions between the agency, the public and the companies that the FDA regulates.
As Dr Armando Oliva, FDA Deputy Director for Bioinformatics, commented: “it’s fair to say that the Agency is actively moving toward an electronic world where all regulated product information comes in electronically. I couldn’t tell 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” (1). |
