Interpretation of the Policy is significant for Mesoblast and its requirements to the FDA
https://www.fda.gov/downloads/Biolo...uidances/CellularandGeneTherapy/UCM585403.pdf
Do MSB's products fall under the category of Homologous use?
Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.
The interpretation of the regs and definition of MSB'd products ie; structural or non structural cells, homologous or non-homologous could make a big diff to how its products are regulated via this flow chart.
FDA announce new policy approach, page-30
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