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

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 dis-cuss 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, focuss-ing on new opportunities to embed microphysio-logical systems.