The FDA has launched an Expedited Investigational New Drug pilot program aimed at shortening time to first-in-human trials in the U.S. The initiative, described as part of Operation Trialblazer, selects qualified research institutions to support rolling review as components of IND submissions arrive. Up to 10 research institutions are expected to be selected, with applications due Oct. 30. The FDA intends to set up institution–drugmaker pairings (target eight to 10) to work through the expedited pathway that is meant to counter sponsor behavior moving early trials overseas to use faster regulatory timelines. The agency framed the bottleneck as time and uncertainty from discovery to first-in-human, citing that bringing programs into U.S. clinical trials can take up to two years—while companies can shave months by starting trials in jurisdictions such as Australia and China.