REGULATORY UPDATE: New CBER Report Highlights 2023 Activities

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) published a report from agency director Peter Marks, MD, PhD, highlighting the agency’s actions during calendar year 2023. The report covers the approval of therapeutic products and vaccines, as well as advancements in cell and gene therapies. In addition, Marks discusses ongoing efforts to support clinical trials for rare diseases, leverage platform technologies and implement accelerated approval pathways. Marks also notes a significant milestone for the agency and the LGBTQI+ community with the issue of updated guidance for assessing blood donor eligibility using questions based on individual donor assessment (IDA) to reduce the risk of transfusion transmitted HIV. The report concludes with an outline of organizational updates within CBER and the agency’s goals for 2024.