In this 175th year of the ASA, a reflection on the importance of statistics in US drug regulation is timely. I will look back to the early days of the FDA and describe the evolution of biostatistics as a discipline in the Center for Drug Evaluation and Research (CDER). The growth of biostatistics in size -- from a single CDER division to an office of over 170 employees, and in mission --from a group focused on fundamental concepts of clinical trials to a group now engaged in numerous and varied aspects of drug development and both pre- and post-market regulation, will be chronicled. Moving to the present day, I will give a broad overview of the statistical issues and review challenges we face now. Areas that hold opportunity for statisticians to provide innovation and play a leadership role in drug regulation in the future will be highlighted.