The FDA modernisation act 2.0: Bringing non-animal technologies to the regulatory table

Alastair Stewart; Delphine Denoyer; Xumei Gao; Yi-Chin Toh

doi:10.1016/j.drudis.2023.103496

The FDA modernisation act 2.0: Bringing non-animal technologies to the regulatory table

Drug Discov Today. 2023 Apr;28(4):103496. doi: 10.1016/j.drudis.2023.103496. Epub 2023 Jan 20.

Authors

Alastair Stewart¹, Delphine Denoyer², Xumei Gao², Yi-Chin Toh³

Affiliations

¹ ARC Training Centre for Personalised Therapeutics Technologies, Department of Biochemistry and Pharmacology, School of Biomedical Sciences, University of Melbourne, Australia. Electronic address: astew@unimelb.edu.au.
² ARC Training Centre for Personalised Therapeutics Technologies, Department of Biochemistry and Pharmacology, School of Biomedical Sciences, University of Melbourne, Australia.
³ School of Mechanical, Medical and Process Engineering, Centre for Biomedical Technologies, Queensland University of Technology, Australia.

PMID: 36690176
DOI: 10.1016/j.drudis.2023.103496

Abstract

The FDA modernisation Act 2.0 marks a game-changing legislation enabling drug registration without the absolute requirement for the use of animals in safety toxicology assessment. We discuss landmark developments in the legislation under which the FDA operates and consider the implications of this most recent chapter in the evolution of the drug regulation pathway, focussing on new opportunities to embed microphysiological systems.

Keywords: Cell culture; Microfluidics; Microphysiological systems; Organoids; Regulatory pathways; Safety pharmacology.

Publication types

Editorial
Research Support, Non-U.S. Gov't

MeSH terms

Animals
Microfluidics*
Technology*