The FDA used the 2027 budget proposal to float policies aimed at encouraging domestic development and manufacturing of drugs, including a potential faster route to first-in-human studies. The proposal would create an “optional, risk-based” expedited Investigational New Drug pathway for experimental drugs that have adequate preclinical data, reducing reliance on additional work before entering human trials. The agency’s framing links the policy push to competitive pressure from China’s earlier-stage clinical development activity, which it says has shifted momentum away from the U.S. FDA Commissioner Marty Makary said the agency needs “giant, big ideas” to respond. If enacted, the reforms could also lower development costs and time-to-trial in the U.S. by changing how certain candidates move through preclinical confirmation requirements. Congressional action would still be required to implement the pathway. For biotech companies, the signal is that regulatory flexibility may be available to some programs—particularly those with robust preclinical packages—while broader policy incentives continue to reward domestic manufacturing and earlier U.S. trial engagement.