On Mar. 16, 2004, the Food and Drug Administration (FDA) released a report addressing the recent slowdown in innovative medical therapies submitted to the FDA for approval, “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.”

The report described the urgent need to modernize the medical product development process, the Critical Path, to make product development more predictable and less costly.

Under an agreement between FDA and the National Cancer Institute (NCI), the two agencies agreed to share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients.