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STAT Plus<br>Biotech
FDA to launch pilot program to speed up early-stage clinical trials
Health officials tout effort to develop drugs more quickly, compete with China
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By Chelsea Cirruzzo and Lizzy Lawrence<br>June 22, 2026
Chelsea Cirruzzo
[email protected]
Chelsea covers the Department of Health and Human Services with a particular focus on power and influence at the top. Confidential tips can be sent via Signal at chelseacirruzzo.42.
Lizzy Lawrence
[email protected]
Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.
WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they say will reduce development timelines by six to 12 months, in hopes of encouraging U.S.-based trials and combating Chinese dominance in the field.
The pilot comes as the Food and Drug Administration, through the president’s 2027 fiscal budget, asks Congress to establish a permanent, faster process for the existing Investigational New Drug pathway. That proposal was championed by former FDA Commissioner Marty Makary before he resigned last month, though officials said on a Monday morning call that this program had been in the works since the start of the administration.<br>Advertisement
In a Fox News op-ed, health secretary Robert F. Kennedy Jr. wrote that the U.S. is “losing ground” against China in clinical research and touted the actions as a way to reverse that trend.
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biotechnology, Clinical trials, drug development, FDA, HHS, Pharmaceuticals, Policy, research, STAT+
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Chelsea Cirruzzo
Washington Correspondent
Chelsea covers the Department of Health and Human Services with a particular focus on power and influence at the top. Confidential tips can be sent via Signal at chelseacirruzzo.42.
Lizzy Lawrence
FDA Reporter
Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.
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