Latest news from the Center for Biologics Evaluation and Research

Office of Therapeutic Products Events, Meetings, and Workshops

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, June 4, 2024, to answer stakeholder questions regarding the chemistry, manufacturing, and controls (CMC) information submitted with biologics license applications (BLAs) for gene therapy products. Expe

Notifying FDA of Fatalities Related to Blood Collection or Transfusion, CBER, biologics, guidance, industry, blood, transfusion, fatality, safety

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.