Biotechnology has evolved from a research platform into nearly 100 pharmaceutical drug products and myriad other commercial applications, ranging from predictive genetic tests to industrial processes and agricultural products. The evolution of biotechnology has taken place during an era of advancement of information technology that has introduced an unprecedented level of international communication and promoted globalisation. Biotechnology's extraordinary evolution in the USA is largely attributable to supportive federal policy and the resulting infrastructure. However, the US now faces some significant challenges that threaten to set its biotechnology establishment back significantly, or at least significantly impede the pace of future progress. Pressing regulatory and policy challenges to the continued advancement of biotechnology along the R&D continuum are of unprecedented complexity. The USA, as the primary developer and exporter of this technology, faces global policy and regulatory challenges to economic expansion and continued commercial success. The pace of accomplishment is contingent on US ability to continue to demonstrate regulatory responsiveness in the face of increased complexity and challenges of a global economy.