Center for Biologics Evaluation and Research

The Center for Biologics Evaluation and Research (CBER) is a division within the U.S. Food and Drug Administration (FDA) responsible for regulating biological products, including vaccines, blood and blood products, and gene therapies. CBER ensures the safety, purity, potency, and effectiveness of these products. CBER is newsworthy because the FDA recently declined to review Moderna's application for a new flu vaccine. This decision, made under the Trump administration, has raised concerns about potential political influence on vaccine approvals and could have broader implications for the review process of new and updated vaccines in the US. The FDA's refusal to review Moderna's flu vaccine application, despite prior approval of the project, highlights the complexities and potential uncertainties in the regulatory pathway for new biological products.