Focus Forward: Facing Challenges and Embracing Regulatory Science

The 2009 RAPS Annual Conference featured two very different keynote speakers who both challenged the regulatory profession. US Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg talked about the challenges of good regulation-combining good science with reasonable levels of risk and effective processes. Dr. Hamburg emphasized the need for regulatory science (more about that in a bit) to be the underpinning of the regulatory profession and to provide the foundation of regulatory policy and processes. She also noted the shared responsibilities of industry and regulatory agencies. She was speaking specifically about FDA, but the idea is broadly applicable.