Why is the FDA the right entity to take responsibility for improving the Critical Path?
The FDA is not taking sole responsibility for improving the Critical Path. But it is the only entity capable of creating the focus necessary for this task. FDA is uniquely suited to serve as a hub for this effort, because it oversees evaluation of all U.S. medical products, and can identify the key product development hurdles that commonly cause setbacks for companies industry-wide. Because FDA is not a product development competitor, it can serve as a convenor for the coordination and information sharing necessary to identify and eliminate Critical Path hurdles. And because FDA sets the scientific standards for product development, only FDA can ensure that new Critical Path tools become the new standards for proving efficacy, assessing safety, and manufacturing medical products. But industry, academic researchers, patient advocacy groups, and others are needed to do their part. Many of the Opportunities on the national Critical Path Challenges List will remain merely that — unmet opp
