FDA has announced a new draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The document was issued in April 2024 by the agency’s Center for Biologics Evaluation and Research (CBER) (1).
According to FDA in an April 30, 2024 notice in the Federal Register (2), “Allogeneic cells of human origin may be expanded in culture to manufacture medical products consisting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles.” Thus, the draft guidance provides recommendations to help sponsors of allogeneic cell-based medical products determine what cell safety testing is appropriate to support an investigational new drug application (IND) or a biologics license application (BLA).
