The FDA’s Critical Path Initiative is intended to integrate new science in to the regulatory process. This is an effort which requires the investment and partnership of industry, academia, health organizations, and government agencies. The guiding principles of this initiative include collaborative efforts among stakeholders, developing standards, generating support for sharing existing knowledge, database development, building infrastructure and “toolkit” development rather than product-specific development, and most importantly, sharing this information publicly. The goal of this discussion will be to describe the efforts of the FDA to date regarding the Critical Path Initiative specifically in the areas of developing better evaluation tools and streamlining clinical trials.