FDA Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products (Catapult's regulatory round-up - May 2024)

FDA has issued a draft guidance intended to sponsors of allogeneic cell-based medicinal products, to provide recommendations for determining the appropriate cell safety testing to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). Cell safety testing should be based on a risk analysis that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical ...