Hot Topic Discussion with FDA: Cold-Stored Platelets (23EL-896) – Free for AABB Individual Members!

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

• Program Description

  Join the Food and Drug Administration for a Hot Topic Discussion on cold-stored platelets (CSPs). In this program, representatives from FDA will answer questions and discuss considerations and concerns related to cold-stored platelets and the agency’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.” The program will also focus on the regulatory history and rationale for cold-stored platelet components and describe the available evidence for their use in the treatment of active bleeding. The FDA will respond to the most frequently asked questions upfront.

  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.

  Program Faculty

  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

  Continuing Education Credit

  This activity is eligible for 0.75 continuing education credit/contact hour for California-based nursing professionals and General Participation credit. AABB reserves the right to reduce or increase the number and type of credits granted for this program (live or on-demand) based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage. Please note: this program is not eligible for California Lab Personnel, Florida Lab Personnel or continuing medical education credit for physicians.

  Register