H.R. 2821: FDA Modernization Act 3.0

The mismatch dates to the Consolidated Appropriations Act, 2023, which carried the change widely known as the FDA Modernization Act 2.0. It rewrote the drug law so a company could support a new drug with "nonclinical" tests, a category that covers cell-based assays, organ chips, computer models, and animal studies alike. FDA's own regulations were never updated to match.

H.R. 2821 orders FDA to swap "animal" for "nonclinical" across 21 named regulations within a year, with the change taking effect immediately. The list touches applications to begin human trials, full approval applications for brand-name and generic drugs, diagnostic radiopharmaceuticals, over-the-counter drug reviews, and biologics. A catch-all lets FDA fix any other regulation that conflicts with the 2022 law.

The bill also writes the statute's definition of a nonclinical test into four core definition sections of FDA's rules, so reviewers and companies read the same term the same way.

Normally an agency that skips public comment before a rule takes effect has to justify the shortcut. This bill waives that step. FDA publishes, the rule is live, and comments can come afterward.

Animal testing stays legal and stays on the list of acceptable evidence; what changes is that the rules stop treating it as the only kind. A final housekeeping fix relabels a duplicate subsection in the drug law so two unrelated provisions no longer share the same letter.