2024 Safety and Availability Communications
This webpage was developed to provide the public with important information about the safety and availability of biological products.
December 2024
- Update to Important Information about Young Donor Plasma Infusions Offered for Profit
December 6, 2024 - Important Information for Blood Establishments Regarding Cybersecurity Resiliency
December 5, 2024
November 2024
- FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)
November 27, 2024 - Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding the Oropouche Virus and HCT/P Donation
November 1, 2024
October 2024
- Important Information on Use of Unapproved Human Immunodeficiency Virus (HIV) Blood Sample Self-Collection Kits
October 29, 2024 - October 2024 Dear Healthcare Provider Letter - Extension of expiration dates for JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non-replicating)
- Extension of the Expiration Date for 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) Lot 5859955 through April 1, 2025 and 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) Lot 6040410 through September 1, 2025
- Public Safety Notification on Amniotic Fluid Eyedrops
October 17, 2024 Update
September 2024
- Important Information for Blood Establishments Regarding the Oropouche Virus and Blood Donation
September 13, 2024
June 2024
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)