The FDA is proposing a new, optional, risk-based expedited Investigational New Drug pathway aimed at reducing time to first-in-human studies for drugs with adequate preclinical data. The plan is designed to lower regulatory burden and development costs while aligning the U.S. more closely with a framework that has shifted early clinical activity abroad. In parallel, the administration’s budget language is also being used to support policy changes intended to speed clinical timelines and bolster U.S. drug development and manufacturing capacity. The proposals underscore an increasingly proactive FDA stance on speeding early-stage experimentation, though they would require Congressional action. Separately, BIOCentury reports the FDA commissioner is using budget proposals to push “giant, big ideas” to counter China’s lead in early-stage development, including options to make it easier to run early trials in the U.S. and to provide advantages for U.S.-based generics manufacturers.