2024 Safety and Availability Communications
This webpage was developed to provide the public with important information about the safety and availability of biological products.
April 2024
- Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding the Recall of Certain Saline and Sterile Water Medical Products by Nurse Assist
April 26, 2024 - FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
April 18, 2024
January 2024
- January 23, 2024 Safety Labeling Change Notification Letter - TECARTUS (brexucabtagene autoleucel)
- January 19, 2024 Safety Labeling Change Notification Letter - ABECMA (idecabtagene vicleucel)
- January 19, 2024 Safety Labeling Change Notification Letter - BREYANZI (lisocabtagene maraleucel)
- January 19, 2024 Safety Labeling Change Notification Letter - CARVYKTI (ciltacabtagene autoleucel)
- January 19, 2024 Safety Labeling Change Notification Letter - KYMRIAH (tisagenlecleucel)
- January 19, 2024 Safety Labeling Change Notification Letter - YESCARTA (axicabtagene ciloleucel)