Regulatory Submissions: From CANDA/CAPLA to 2002 and Beyond

Abstract

Vast amounts of scientific information and scientific-regulatory documentation are generated in the biopharmaceutical industry. The positive impact of recent technological advances on the creation, sharing, storage, compilation, and presentation of regulatory documentation is well recognized. In the United States, the ultimate customer and consumer of this myriad of information is the Food and Drug Administration (FDA), whose charter is to protect and advance the state of human health. There is a positive story to be told regarding the interactions between industry and the FDA which has led to hundreds of safe and effective, life-enhancing medical treatments being made available to the public. There is also a story within the story regarding how those parties working toward a common goal advanced the state of information exchange, from one that was totally paper based to one that now has the potential to become totally digital in format. The authors' intent is to recount that story and to provide evidence in support of the notion that refining the practice of digital information exchange will further streamline the regulatory review process.

Keywords

Computer-Assisted New Drug Applications (CANDAS)Adobe Acrobat Electronic regulatory submissions Publishing systems 1999 Guidance

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