The FDA proposed a faster regulatory path for first-in-human (FIH) Phase I trials to boost US competitiveness, including a “clinical trial notification pathway” included in its 2027 budget request. The approach is intended as an alternative to the traditional investigational new drug process for certain Phase I trials when validated preclinical data exist. Under current rules, sponsors build toxicology and pharmacology packages that face FDA review and a separate institutional review board assessment before advertising and enrollment activities begin. The new pathway aims to reduce duplicative, time-consuming requirements while preserving safety and ethical standards. The FDA explicitly linked the proposal to barriers faced by smaller biotechs, describing how early-stage activity has increased in jurisdictions including China and Australia where notification-based timelines can be faster.