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

Congratulations to GCI Research Theme Lead Prof Alastair Stewart, along with Delphine Denoyer, Xumei Gao from the University of Melbourne and Yi-Chin Toh from Queensland University of Technology on their recent editorial published in Drug Discovery Today journal.

Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed.

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, focusing on new opportunities to embed microphysiological systems.

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