The FDA's Center for Biologics Evaluation and Research (CBER) Office of Blood Research and Review (OBRR) is hosting a public webinar on Wednesday, February 19, 2025, from 8:00 AM - 1:00 PM ET.

DRAFT AGENDA

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 registrants.

In 2021, blood establishments in the United States collected approximately 15 million blood components for 14.5 million transfusions. In addition, Source Plasma establishments collected approximately 43 million units of Source Plasma in 2021. OBRR regulates the collection of blood and blood components used for transfusion or for the manufacture of plasma derived products to ensure the safety of the blood supply and to protect the health of blood donors. This webinar will discuss topics relevant to the manufacture of blood and blood components including Source Plasma and address questions submitted by participants ahead of the meeting.

This meeting is free and open to the public; however, registration is required. Early registration is recommended.

Please note, FDA is not able to comment on or answer questions regarding specific investigational new drug submissions, or biologics license applications, or draft guidance documents during the webinar. Further, questions considered out of scope for the event will not be addressed.