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US Launches Trailblazer as China Holds 32% Trials

6/24/2026

Summary

HHS Launches Trailblazer

HHS launched Operation Trailblazer to restore American clinical-trial leadership.
China’s share of global trial starts grew from 1% in 2009 to 32% last year.
FDA will pilot faster first-in-human trials that cut timelines by six to 12 months and allow approval from a single pivotal trial.
NIH will boost AI, cell-model and real-world-data support for trials, while the EU, UK and Japan announced comparable initiatives that raise competition for study starts.

Summary

FDA Issues Guidance

FDA opened a public docket for comments on the Expedited IND pilot, deadline 22 July.
Updated CMC IND guidance lets sponsors omit unnecessary stability and commercial-scale data, potentially saving 6–12 months.
Draft guidance introduces quantitative systems pharmacology methods to select MABEL doses for first-in-human trials.
FDA created a Phase 1 Contact Center (240-276-9358 or Phase1Questions@fda.hhs.gov) for real-time regulatory queries.

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HHS Launches Trailblazer

HHS launched Operation Trailblazer to restore American clinical-trial leadership.
China’s share of global trial starts grew from 1% in 2009 to 32% last year.
FDA will pilot faster first-in-human trials that cut timelines by six to 12 months and allow approval from a single pivotal trial.
NIH will boost AI, cell-model and real-world-data support for trials, while the EU, UK and Japan announced comparable initiatives that raise competition for study starts.

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