Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma - 05/12/2026
The FDA's Office of Blood Research and Review (OBRR) announced a public webinar scheduled for May 12, 2026, to provide an overview of the Biologics License Application (BLA) review process for blood, blood components, and source plasma. Officials will present on select topics and address stakeholder questions submitted by registrants.
This update affects blood establishments, source plasma manufacturers, and regulatory affairs professionals involved in the manufacture and licensing of blood-derived products.
Direct engagement from OBRR staff regarding BLA review approaches suggests a focus on improving the quality and transparency of submissions for blood-related products. This webinar may provide critical insight into current agency expectations for manufacturing data and application structure, potentially reducing the likelihood of submission deficiencies or delays for firms seeking licensure.
Regulatory and QA teams at blood establishments should register for the webinar and prepare specific technical questions regarding BLA submission hurdles. Internal teams may benefit from reviewing current BLA manufacturing sections ahead of the event to align internal processes with the OBRR review overview.
This webinar is intended to provide blood establishments and other stakeholders with an overview of OBRR’s approach to the review of biologics license applications for the manufacture of blood and blood components, including source plasma. In this event, OBRR staff will give presentations on select topics and address questions submitted by registra
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