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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Defined term · Regulatory

Boxed warning

The most prominent warning a competent authority can require in product information. Signals regulatory concern; does not itself establish that the risk is realised in humans.

Document identifier
CEI-GT-178
Series
Defined term
Version
1.0
Published
30 Jul 2026
Last reviewed
30 Jul 2026
Certainty
Not rated

§1Boxed warning

§1.1Also known as

Black box warning

§1.2Category

Regulatory — Terms describing the status of a compound before a competent authority.

§1.3Related terms

  • Pharmacovigilance — The collection and analysis of reports of suspected adverse reactions after authorisation. Establishes that an event has been reported and, for an event named in a…
Compound Evidence Institute · CEI-GT-178 · https://compoundevidence.com/glossary/boxed-warning/ · retrieved 30 July 2026
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