FDA Webinar to Explore BLA Review for Blood and Source Plasma

The Food and Drug Administration will host a public webinar May 12 to provide blood establishments with an overview of the agency’s approach to reviewing biologics license applications (BLAs) for the manufacture of blood, blood components including source plasma.

Organized by the Center for Biologics Evaluation and Research Office of Blood Research and Review, the webinar will outline regulatory requirements and processes related to BLAs, including submission expectations, review procedures and common deficiencies. Additional topics include blood establishment registration, pre-license and pre-approval inspections, and requirements for testing, donor deferral and notification related to transfusion-transmitted infections.

The webinar is free and open to the public, but registration is required. A recording and related materials will be made available following the event.