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FDAAA 801 Compliance Watch — a maintained view
A maintained, aggregate view of FDAAA 801
results-reporting compliance — who is supposed to post clinical-trial
results, how large the overdue backlog appears, and what FDA enforcement is
actually doing about it. Updated from Eichor's daily registry scan.
Honoring the pioneers. The
Oxford EBM DataLab
FDAAA TrialsTracker invented public FDAAA-801 accountability and inspired
this page. Like most unfunded academic tools, it has struggled to stay
maintained — it previously went dark for over a year after a registry API
change.
Current status of the original (from our weekly automated
check): active — reachable; no parseable freshness date (our last check: 2026-07-27).
Their tool is currently active — good. We maintain this complementary aggregate view regardless, so the public record never again depends on a single unfunded project.
The numbers (our measurements, updated daily)
- Eichor Overdue-Results Index:
984 trials currently in our rolling index of apparently overdue results
— trials appearing completed >12 months ago with no results posted
(the reporting expectation associated with FDAAA 801; individual applicability
varies). This is a coverage figure of a standing backlog, not a rate —
methodology & live JSON.
- Newly indexed in the past 7 days:
171 trials added to the index by our scan.
- Official FDA enforcement (FDA's own public table): 8 notices of noncompliance on FDA's public record, 0 carrying civil monetary penalty amounts; most recent notice dated 08/04/2025. FDA names the parties on its official table — we cite the counts and leave the names to the regulator.
How this differs from the original — on purpose
- Aggregate only. The original ranked and named individual
sponsors from registry math. We don't: registry-derived lateness is an
appearance with legitimate exceptions (delay certifications,
submissions in QC review), and naming from heuristics risks false accusations.
Names belong to the regulator's official record, linked above.
- Maintained as infrastructure. This page is generated by
the same daily pipeline that powers our paid monitoring products — it stays
alive because the business does.
- The private door: any sponsor can check their own
portfolio's status in minutes — free, verified against the same exceptions:
free disclosure check.
Figures are Eichor's own measurements
from public ClinicalTrials.gov records, not statistics published by
ClinicalTrials.gov or FDA (except the FDA enforcement counts, cited from FDA's
public table). Cite as: "Eichor (eichor.com/fdaaa)". Related:
live facts feed · weekly briefs.
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