The U.S. Food and Drug Administration said on ​Monday it is launching a ‌series of measures to ​speed up drug research, from ⁠early-stage investigational studies to late-stage trials, under an initiative called Operation TrialBlazer.

Here ‌are some details:

* The FDA said it is ‌planning a new pilot ‌program ⁠that would pair drug sponsors ⁠with qualified research institutions such as academic medical centers and contract research ​organizations to shorten ‌the time from drug identification to first-in-human studies.

* It separately updated its guidance for early-stage studies, ‌saying a more phase-appropriate ​approach could save companies six to 12 months of ⁠development time.

* In late-stage development, drugmakers may be able ‌to rely on one rigorous, well-controlled pivotal trial plus confirmatory evidence, rather than multiple pivotal studies, for approval.

* The agency also launched a webpage ‌to bring together regulatory requirements, guidance ​and examples in one place, aimed in part at ⁠helping smaller companies.

* It said a ⁠new Phase 1 Contact Center will provide real-time ‌answers on protocols, regulatory requirements and other early-trial questions.

Published on June 23, 2026