In March 2026, the FDA issued notification messages to more than 2,200 sponsors, covering 3,000+ clinical trials, reminding them to submit required results to ClinicalTrials.gov. These notices represent nearly 30% of all U.S. Nexus studies that are highly likely to fall under mandatory reporting requirements.
By contacting sponsors directly—and pairing that outreach with a public press release—the FDA is signaling a move toward more active enforcement, including potential civil monetary penalties.
What This Means for You
Whether you received an FDA notification or not, now is the time to act.
If You Identify Gaps, We’re Here to Help
If you discover missing results — or even suspect you may be at risk — Citeline can support you at every step. TrialScope Disclose, our end‑to‑end disclosure management platform, is the industry’s leading solution for global clinical trial transparency. It centralizes and streamlines your entire workflow — from trial planning through results submission — ensuring:
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Access practical tools and real-world examples that show how organizations like yours stay ahead of regulatory expectations:
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In this use case, a sponsor in the early stages of planning a breast cancer clinical trial wanted to address potential stumbling blocks from the start.
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SIn this use case, a pharmaceutical sponsor preparing for its first clinical trial in Switzerland needed clarity on local registration requirements, disclosure timelines, and the correct submission platform.
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AI has embedded itself in clinical development to accelerate decisions, reduce manual burden, and improve outcomes.
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Manage end-to-end disclosure processes from protocol registration to trial results submission with TrialScope Disclose.
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