Innovations in Skin Microphysiological Systems for Nonclinical Testing and FDA Modernization

The document discusses advancements in skin microphysiological systems (MPSs) for nonclinical testing, emphasizing their potential to replace animal models due to the FDA Modernization Act 2.0. These systems, including skin-on-a-chip devices and skin organoids, better replicate human skin's architecture and functions, aiding in disease modeling and drug evaluation. Innovations in 3D bioprinting and bioinks have improved human skin equivalents, while skin organoids offer personalized disease modeling for conditions like alopecia. Despite challenges such as high validation costs, structural heterogeneity, and slow regulatory acceptance, MPSs provide more physiologically relevant platforms for preclinical testing. The document highlights the need for standardized protocols and advanced analytical tools to enhance reproducibility and regulatory adoption, ultimately advancing precision medicine and cosmetic safety.