Since its enactment in 1938, FDA has seen an enormous increase in the magnitude and complexity of its regulatory responsibilities. New areas of science, evolving technologies, and globalization have profoundly altered the Agency's regulatory landscape.

Today FDA's regulatory activities range from developing new models to assess the safety of gene therapy to building a new prevention-based food safety system for a globalized economy and creating a national electronic system that will track the safety of FDA-regulated medical products once they reach the market.

However, the success of these efforts depends on an FDA that is positioned to incorporate emerging technologies into the tools and approaches it uses to monitor and evaluate the safety and efficacy of new and licensed products.