FDA Modernization Act 3.0 (HR2821)

Current understanding

HR2821, the FDA Modernization Act 3.0, is a 119th Congress bill that would further advance FDA’s authority to accept non-animal testing methods (such as cell-based assays, organ-on-chip, and computational models) for drug and biologic approvals, building on the FDA Modernization Act 2.0. As of June 2026, the bill was placed on the Union Calendar, positioning it for House floor consideration.

Evidence log

• 2026-09-22 — Nonclinical Testing Terminology: cross-connection with fda-nonclinical-testing: Both advance the shift away from mandatory animal testing in FDA drug-safety review; the terminology rule operationalizes language consistent with FDA Modernization Act authorities. (novelty: 2)
• 2026-07-13 — Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments: 2026 — Separate FDA proposed rule updates drug establishment registration/listing to accommodate distributed manufacturing and PREVENT Pandemics Act changes, reflecting ongoing modernization of FDA administrative frameworks alongside HR2821. (novelty: 2)

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