FDA animal testing phaseout urges AI-based trial alternatives, organoids, other “NAMs”
By EsqSocial Corporation 07/05/25
The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective, human-relevant methods.” Although fully replacing animal tests may be a lengthy process, FDA’s plan aims to accelerate the adoption of new approach methodologies (NAMs) outlined in recent updates to 21 USC 355 (z) under the 2022 FDA Modernization Act 2.0. This expansion broadens the...
By: Hogan Lovells