Updated FDA Guidance to Reduce Risk of Transmission of Creutzfeldt-Jakob Disease The U.S. Food and Drug Administration (FDA) has issued updated guidance to reduce the transfusion-related transmission risk of Creutzfeldt-Jakob disease… June 1, 2022
Updated Transfusion Guidelines for High-Risk Surgery Patients Patient blood management programs use a multimodal approach to conserve blood and simultaneously improve patient outcomes. Transfusion guidelines are central… February 16, 2022
Minimal Concerns for HIV in the US Blood Supply after FDA Revised Guidance In 2015, the U.S. FDA revised guidance for blood donor deferral of men who have sex with men (MSM) from… September 15, 2020
FDA Issues Emergency Use Authorization for COVID-19 Convalescent Plasma To increase access to COVID-19 convalescent plasma (CCP) use, President Trump, in conjunction with the U.S. FDA, announced Emergency Use… August 25, 2020
Coagulopathy in Patients with COVID-19—Interim Guidance from the International Society on Thrombosis and Haemostasis Although the pathophysiology of severe COVID-19 is poorly understood, coagulopathy near the lungs has been shown to play an important… May 13, 2020
FDA Alters Blood Donor Eligibility Guidelines during COVID-19 Public Health Emergency The U.S. Food and Drug Administration (FDA) issued four blood donor eligibility guidelines on April 2, 2020 to help alleviate… April 7, 2020
Final FDA Guidance to Reduce Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II Transmission of the retroviruses human T-lymphotropic virus types I and II (HTLV-I/II) require cell-to-cell contact—mother to child transmission, sexual transmission,… February 12, 2020
New Draft Guidance Recommendations from the FDA to Reduce Risk of Transfusion-Transmitted Creutzfeldt-Jakob Diseases Creutzfeldt-Jakob Disease (CJD) is a fatal, rare neurological disease caused by infectious prions, or abnormally folded proteins. Sporadic CJD accounts… February 5, 2020
FDA Guidance to Control for Bacterial Contamination in Platelets The U.S. Food and Drug Administration (FDA) has issued final guidance to reduce bacterial contamination of platelets stored at room… October 9, 2019
New FDA Recommendations for Babesiosis Screening of Blood Donations Babesiosis, caused by a tick-borne intra-erythrocytic parasite, is normally asymptomatic in humans but can cause severe and even deadly flu-like… May 16, 2019
Policy and Guidelines