AABB has developed a fact sheet for clinicians considering the use of COVID-19 convalescent plasma that reflects the changes in the Food and Drug Administration’s revised emergency use authorization for CCP.
Based on concerns and questions from hospitals and blood centers about inventory management strategies, AABB has confirmed its understanding with the Food and Drug Administration to help members identify existing flexible shipping options that are widely misunderstood.
The Food and Drug Administration issued a revised final guidance on Friday that provides updated recommendations on the use of COVID-19 convalescent plasma (CCP) related to the December 2021 emergency use authorization (EUA) for CCP.
The Food and Drug Administration revised the emergency use authorization (EUA) for COVID-19 convalescent plasma (CCP) on Dec. 28 to permit the use of high-titer CCP for treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment.
The slide presentation from the 2021 AABB Virtual Annual Meeting session “Ask the FDA and CLIA/CMS” is now available with responses from each agency’s representatives included in the slides.