FDA to Host Webinar on BLA Review for Blood and Source Plasma

FDA’s Center for Biologics Evaluation and Research (CBER) Office of Blood Research and Review (OBRR) will host a public webinar May 12 to provide an overview of the review process for biologics license applications (BLAs) for blood and blood components, including source plasma.

The virtual event will include presentations on BLA submission and review processes, manufacturing requirements, and pre-license and pre-approval inspections, including common citations. FDA will also address pre-submitted questions from stakeholders.

Registration is required by April 10 to attend. FDA will publish a recording following the event.

AABB plans to submit questions for FDA consideration and encourages members to share questions directly with FDA or with AABB via email.