AI Article Synopsis
- The FDA Modernization Act 2.0 allows for drug registration without needing animal testing for safety assessments, making a significant change in drug approval processes.
- The legislation represents important advancements in the regulatory framework of the FDA, reflecting a shift towards more innovative testing methods.
- The act opens up new opportunities for using microphysiological systems in drug development, potentially leading to more ethical and efficient research practices.
Article 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.
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| http://dx.doi.org/10.1016/j.drudis.2023.103496 | DOI Listing |
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