Distinguish terminology, method suitability and evidentiary standards.
What FDA explicitly states
FDA’s September 21, 2026 announcement explains changes from certain animal-testing terms to nonclinical-testing terms. It states that the update does not prohibit animal studies, change evidentiary standards or impose new requirements.
Sources [1]
NAMs are a set of approaches, not automatic acceptance
FDA describes NAMs including human-based in vitro systems and computational approaches. Suitability depends on the scientific question, validation and context of use. Calling an approach a NAM does not itself demonstrate that an individual study meets an evidentiary requirement.
Sources [2]
Keep the document version and status
A useful policy note records the document date, formal rule link and methods actually used in the study. FDA also explains the comment and possible withdrawal process for the direct final rule. A claim that all data on file become invalid goes beyond the announcement.
Original sources
These notes explain public references; they do not replace sample-specific testing or case-specific professional judgment.