AABB's Regulatory Toolkits for Members
The AABB Regulatory Affairs staff have developed these Toolkits and “Member Offerings” to equip our members with the most up-to-date, practical tools to guide you through regulatory decision-making processes.
- 2022-2023 Regulatory Updates Toolkit (member-protected)
- 2021 Regulatory Updates Toolkit (member-protected)
- 2019-2020 Regulatory Updates Toolkit (member-protected)
- Resources to Support FDA's Voluntary TB Risk Mitigation Strategies for HCT/P Establishments and Transfusion Services - Updated March 14, 2024 (UNLOCKED)
- Implementation of Cold-Stored Platelets - Toolkit - Updated December 2023 (member-protected)
- DHQ v4.0 Spanish Language Translation Toolkit – Examples to Consider - August 2023 (member-protected)
- IDA and DHQ v4.0 and Accompanying Materials - Toolkit for Implementation - August 2023 (UNLOCKED)
- Mpox Resources to Consider – February 2024 (UNLOCKED)
- User Guide for the December 2021 Circular – March 2022 (UNLOCKED)
- Current Regulatory Options for Collections from Female Blood Donors with Hemoglobin Levels of 12.0 - <12.5 g/dL - January 28,2022 (UNLOCKED)
- Blood Supply: Summary of Crucial Regulatory Options Already Available from FDA - January 20, 2022 (UNLOCKED)
- COVID-19 Convalescent Plasma under Emergency Use Authorization –
January 14, 2022 (UNLOCKED)
- Live with FDA on the CCP Regulatory Landscape – October 28, 2020 (UNLOCKED)
- HCV Testing, Lookback and Reentry – June 21, 2022 (member-protected)
- HIV Testing, Lookback and Reentry - October 17, 2021 (member-protected)
- Syphilis Guidance Toolkit - December 9, 2020 (member-protected)
- HCV Further Testing Toolkit – November 2019 (member-protected)
- Ebola Toolkit - May 2020 (member-protected)
- Babesia Toolkit – September
2019 (member-protected)
- Regulatory Resources for Transfusion Services (member-protected)
- Transfusion Services: FDA Registration Requirements when Extending Platelet Expiration to Day-6 or Day-7 - June 23, 2021 (member-protected)
- BLA Checklist for Plasma Collected by Apheresis – March 25, 2024 (member-protected)
- BLA Checklist for RBCs Collected by Apheresis – March 25, 2024 (member-protected)
- BLA Checklist for Platelets, Leukocytes Reduced Collected by Apheresis – March 25, 2024 (member-protected)
- AABB Checklist for Historic Antigen Labeling – January 2019 (member-protected)
