Vessey 1986 Scientific Reference as FDA Background Material

A 1986 scientific reference has been added to the administrative record for FDA submission FDA-2026-P-3869. This background material provides supporting scientific literature for the regulatory submission. The reference is being considered as part of the evidence base for FDA's review of the associated filing.

Affected parties should note that this document is supporting material and does not independently establish regulatory requirements. Entities with interests in the underlying FDA submission should continue monitoring the docket for the primary regulatory action and any substantive requirements that may flow from the final FDA decision.