The U.S. FDA is considering a faster regulatory pathway for first-in-human (FIH) Phase 1 trials, aiming to cut duplicative review steps for smaller biotech companies. The proposal would create a new “clinical trial notification pathway” as an alternative to the traditional investigational new drug (IND) route in specific first-in-human settings with validated nonclinical methods. In its 2027 budget request, the agency framed the change as a competitiveness move, pointing to the growth of early-stage Phase 1 activity in China and Australia. Under current rules, sponsors must complete toxicology and pharmacology review and separate institutional review board assessment before initiating key trial steps such as advertising and informed consent processes. The FDA did not specify exactly how the new pathway would differ from the IND review beyond applying it to certain Phase 1 clinical trials supported by existing preclinical data. Still, the agency’s stated goals—fewer time-consuming requirements while maintaining safety and ethics—signal a push to reduce early development friction in the U.S.