This is for to know the how was the Regulatory Strategy in use of organoids in preclinical studies to get FDA approval.
Hi
There is no specific guidance by the FDA or guideline by EMA. But some information should be helpful:
https://www.fda.gov/science-research/about-science-research-fda/advancing-alternative-methods-fda
https://www.fda.gov/science-research/fda-grand-rounds/fda-grand-rounds-microphysiological-systems-novel-disease-models-and-drug-development-tools-03092023#event-information
and in general: https://www.fda.gov/search?s=organoid
FDA Definitions
Microphysiological System (MPS):: A microphysiological system uses microscale cell culture platform for in vitro modeling of functional features of a specific tissue or organ of human or animal origin by exposing cells to a microenvironment that mimics the physiological aspects important for their function or pathophysiological condition. MPS design may aim to provide and support cultured cells with physical (e.g., temperature, pH and oxygen)/biochemical/electrical/mechanical (e.g., flow or stretch)/structural/morphological conditions and recapitulate a set of specific properties that define a healthy or diseased organ or tissue function. MPS platforms may comprise mono-cultures, co-cultures of multiple cell types, maintenance of explants derived from tissues/organs, and/or inclusion of organoid cell formations.
Organ-on-a-chip: Organ-on-a-chip is a subset class of microphysiological systems and consists of a miniaturized physiological environment engineered to yield and/or analyze functional tissue units capable of modeling specified/targeted organ-level responses.
Hope it helps
Best regards
Tomasz
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