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DHHS Releases 2026 Unified Agenda With Five Clinical Research Rule Changes
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Fusion42 · 3 October 2026 · Fusion42 review
The 2026 DHHS Unified Agenda includes five proposed regulatory changes affecting clinical research, with key near-term focus on FDA's expedited Phase 1 IND reform and the final-rule on the single IRB requirement for multisite FDA studies, both targeting implementation by late 2026.
This Wire brief sits within Fusion42's coverage of Health.
◆ ◆ The Wire takeaway
Clinical research founders must prioritise adapting to FDA's single IRB final rule ahead of its December 2026 deadline and start evaluating Phase 1 IND changes to avoid compliance risks. These regulatory moves open operational room but demand swift alignment to stay competitive.
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1 source · 3 Oct 2026
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