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Preview: Findings by regulation. This is the page subscribers use. The counts are the FDA record; the filters, the deep dive on each regulation and the observation text are for subscribers. See plans × Close preview

This is the page subscribers use. The counts are the FDA record; the filters, the deep dive on each regulation and the observation text are for subscribers.

Preview of Clinical Precedent (Findings by regulation). This is the page subscribers use. The counts are the FDA record; the filters, the deep dive on each regulation and the observation text are for subscribers.

Findings intelligence

Findings by regulation

The findings FDA has cited in drug and biologic clinical research, sliced by organization type: pick the kind of organization you are vetting (or are) and see which regulations draw findings, whether each is rising or falling, and the actual observation text from real inspections.

Most-cited regulations

Reading the trend: “rising” and “falling” compare the newer half of your window with the older half, using complete fiscal years only (±15% counts as steady); the partial current year is counted in the totals but excluded from the trend. Finding counts reflect what FDA cited — a regulation cited less may mean better industry compliance or fewer inspections of that kind.
Clinical Precedent™ — clinical site intelligence from the FDA record Built from FDA Bioresearch Monitoring data. This release covers CDER and CBER inspections of clinical investigators, sponsors, sponsor-investigators, CROs and IRBs — drug and biologic clinical research. At this time, it does not cover bioequivalence (BEQ), Good Laboratory Practice (GLP), postmarketing adverse drug experience (PADE) or REMS inspections, device trials (CDRH) or veterinary products (CVM). The service reports the record; it does not make recommendations or provide regulatory advice. It does not cover other factors in clinical investigator selection — therapeutic-area expertise, site capabilities, your own history with the clinical investigator, enrollment track record, and your qualification visit. Sources last checked 2026-10-13 — every source is checked daily; updated whenever new FDA information is available. About · Guides · News · Pricing · Contact · Terms of Service · Privacy Policy · support@clinicalprecedent.com Clinical Precedent on YouTube, LinkedIn and X. Clinical Precedent is a division of Elite Tech Media LLC, an Illinois software and simulation engineering firm established in 2008; Clinical Precedent is its registered Illinois assumed name. Clinical Precedent™ and the shield mark are trademarks of Elite Tech Media LLC.