AABB is partnering with the Food and Drug Administration for a Hot Topic Discussion on cold-stored platelets. The program will take place from 12 to 1 p.m. ET on Thursday, December 14.
Ahead of the event, AABB is compiling questions, considerations and concerns from individual and institutional members related to the June FDA guidance, “Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical.”
To make efficient use of time, FDA plans to respond to the most frequently asked questions upfront. Individuals with questions related to the guidance may submit them to AABB Regulatory Affairs via email. The deadline to submit questions is November 22.
The program is still in development. AABB will share additional information in the coming weeks.
