23EL-896: On-Demand Hot Topic Discussion with FDA: Cold-Stored Platelets

Please note: AABB reserves the right to make updates to this program.

Live Program Date: Thursday, December 14, 2023
Program Number: 23EL-896-L

Faculty
(titles and affiliations at the time of the live program)
Moderator: Sharon Carayiannis, MT(ASCP)HP, Vice President, Accreditation, Standards & Quality, AABB
Speakers: Anne Eder, MD, PhD, Director, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), Food & Drug Administration; Carlos Villa, MD, PhD, Associate Director of Special Projects, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), Food & Drug Administration

Program Description
Join the Food and Drug Administration for a Hot Topic Discussion on cold-stored platelets (CSPs) related to FDA’s June 2023 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.”

Learning Objectives
After participating in this educational activity, participants should be able to:

• Summarize the regulatory history and rationale for cold storage of platelet components.
• Describe the available evidence for use of cold stored platelets (CSP) in the treatment of active bleeding, including in vitro studies, clinical studies, and knowledge gaps.
• Apply the recommendations in the June 2023 FDA guidance on 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.