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REGULATORY UPDATE: AABB Updates Toolkit for Implementation of Cold-Stored Platelets to Include Responses From FDA During Recent Hot Topic Discussion

December 19, 2023

AABB is pleased to make available an updated Toolkit for Implementation of Cold-Stored Platelets, which now includes FDA’s responses to questions from the AABB community provided during AABB’s recent Hot Topic Discussion with FDA: Cold-Stored Platelets.

The Hot Topic Discussion began with an introduction by Anne Eder, MD, PhD, director of CBER’s Office of Blood Research and Review (OBRR). Next, Carlos Villa, MD, PhD, OBRR’s associate director of special projects, reviewed the June 2023 Alternative Procedures for the Manufacture of Cold-Stored Platelets Guidance recommendations, regulatory background, overview of available data and responded to pre-submitted questions from the AABB community.

Villa also provided context for the Indications for Use Statement for cold-stored platelets. Villa included the following notable information:

  • “In considering the indications for use of CSP, FDA recognized there would be many different clinical scenarios, each with considerations unique to a given establishment’s patient population and platelet supply.”
  • “We acknowledge that the management of CSP under the current indication statement raises potentially complex questions. For many of the scenarios raised in the questions, we don’t have all of the information necessary for a complete assessment, and we are not able to get into the management of individual establishments’ platelet inventory.”
  • “Recognizing these limitations, we expect that transfusion services will develop SOPs to define the circumstances where conventional platelets are not available, or their use is not practical, based on the unique characteristics of their transfusion service.  Such SOPs may wish to consider supply, anticipated shortages, and transport and storage logistics.”

The Hot Topic Discussion is complimentary to AABB individual members and is available on demand. Individuals with questions may contact regulatory@aabb.org.