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Virtual | Virtual

Event Title
Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma
February 19, 2025

Date:
February 19, 2025
Time:
9:00 a.m. - 2:00 p.m. ET
Organized By:
Organizer

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 9:00 AM - 2:00 PM ET.

AGENDA

PURPOSE OF THE WEBINAR:

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.

OBJECTIVES:

  1. Explain the process for submission and review of biologics license applications for blood and blood components, including Source Plasma  
  2. Describe FDA regulatory requirements for the manufacture of blood and blood components 
  3. Describe OBRR’s pre-license and pre-approval inspection process and common citations.
  4. Address commonly asked questions from blood establishments and other stakeholders.

BACKGROUND:

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.

Meeting Logistics and Registration:

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

  • Date: February 19, 2025
  • Time: 9:00 a.m. – 2:00 p.m. ET
  • Location: This webinar will be held via Zoom.
  • Registration: To register for the webinar, please visit the following link: https://fda.zoomgov.com/webinar/register/WN_JxDH8a0RSdif4OGxv5lxqQ
    Registration will close on Friday, January 17 2025, at 11:59 p.m. ET. A recording and other relevant meeting materials will be posted online following the event. 
  • Submit a Question: Registrants should submit any questions for speakers to CBERPublicEvents@fda.hhs.gov by Friday, January 17, 2025.
    Please include “OBRR Webinar 2025” in the subject line. 

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.

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