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FDA Launches Pilot Program to Speed Early Clinical Trials
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Fusion42 · 18 September 2026 · Fusion42 review
The FDA has launched the final design of its Expedited Investigational New Drug (IND) Pilot program to shorten timelines from drug discovery to first-in-human clinical trials by enabling rolling reviews and partnerships between pharma sponsors and qualified research institutions (QRIs). Applications for the first cohort are open until October 30, 2026, with 8-10 pairs expected to be selected.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
You must act fast to join the FDA’s pilot program that cuts clinical trial delays by shifting reviews earlier and partnering you with top research institutions. This opens a rare regulatory fast lane that redefines how you prepare and begin first-in-human trials.
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1 source · 18 Sep 2026
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