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Search 2,856 companies with active clinical trial reporting violations. Instant risk scores. Real FDA data. Free to search.

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2,856

Companies Flagged

10,212

Trials Overdue

$166B+

Est. Total Exposure

304

FDA Notices Issued

The Enforcement Shift

Why companies are scrambling in 2026

Since 2007, FDAAA 801 has required clinical trial sponsors to post results within 365 days of completion. For 15 years, the FDA issued the law but rarely enforced it — and companies learned they could ignore it with zero consequences.

That changed in 2025. The FDA issued 2,200+ notices in a single sweep on March 30, 2026, signaling a fundamental shift toward active enforcement. Penalties now reach $15,107 per day per trial — and the FDA has made clear criminal referrals are on the table.

For public companies, the exposure is doubled: FDA noncompliance notices may constitute material events requiring SEC disclosure, exposing executives to shareholder liability.

2007

FDAAA 801 Signed Into Law

Results reporting required within 365 days. Penalties written in. Enforcement: none.

2017

Final Rule Takes Effect

Penalties formalized. Loss of federal funding added as consequence. Industry still ignores it.

2025

Enforcement Escalates

FDA begins systematic enforcement. 232 Pre-Notices issued. Criminal referrals threatened.

Mar 2026

2,200+ Companies Notified

FDA sends mass notification sweep. Voluntary compliance window open — Pre-Notices incoming.

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