The first letter of intent into CDER’ ISTAND Pilot Program for organs-on-chip technology.
The FDA’s Center for Drug Evaluation and Research (CDER) has accepted the first letter of intent (LOI) into its ISTAND Pilot Program for organs-on-chip technology. This LOI is for a human Liver-Chip used to assess the risk of DILI in adults to create relevant data for a drug’s investigational new drug (IND) submission. This LOI acceptance marks a major step forward for CIVM in general.