REGULATORY UPDATE: AABB Plans Malaria Testing Survey and Town Hall to Capture Member Feedback

April 10, 2024

In preparation for the May 9 meeting of the Food and Drug Administration’s Blood Products Advisory Committee (BPAC), AABB is taking steps to engage with FDA early in the regulatory process.

This new paradigm, previously successful with planning and preparations for individual donor assessment (IDA) protocols, continues with FDA posting the BPAC briefing document far in advance of the meeting. AABB’s efforts aim to ensure that feedback from AABB-accredited blood collectors is shared for FDA’s consideration.

AABB’s member engagement is focused in the following areas:

Malaria Testing Survey

AABB will distribute a brief survey via email on Thursday seeking insights into the operational impact and considerations for malaria testing at member blood donor centers. Member responses are crucial in shaping AABB’s communications with FDA; AABB urges members to participate by the survey deadline to have their voices included.

Blood Collectors’ Town Hall

In addition, AABB will host a blood collectors’ town hall on Thursday, April 18 at 12 p.m. EDT. This event seeks to engage a diverse cross-section of the blood community on the topic of new malaria mitigation strategies. Invitations to attend will be sent via email this week.

The town hall will feature brief remarks from various stakeholders on what is important to their facilities as FDA considers new malaria mitigation strategies. AABB will collate and share this feedback with the FDA to ensure that members’ perspectives are considered in the regulatory process.

AABB acknowledges that scheduling conflicts may arise for some organizational leaders, making attendance difficult. In such cases, AABB strongly encourages organizations to designate alternative representatives to participate in the town hall.

Finally, AABB invites members to share their considerations and/or concerns related to malaria risk mitigation strategies for 1-3 minutes during the event. Interested individuals should contact Sharon Carayiannis to secure a speaking slot.