What is CBER?

The Center for Biologics Evaluation and Research (CBER) is a crucial component of the U.S. Food and Drug Administration (FDA). It is tasked with the regulation and oversight of biological products, including vaccines, blood and blood products, tissues, and advanced therapeutics. Established to ensure the safety, purity, potency, and effectiveness of these products, CBER plays a pivotal role in protecting public health and advancing the field of biological therapies.

Importance of CBER

CBER's work is vital in safeguarding public health through the regulation of biologics, which are often at the forefront of medical treatments and preventive measures. It ensures that the products available to the public are not only safe but also effective, thus contributing significantly to the control and eradication of diseases. Furthermore, by fostering innovation in the development of biologics, CBER supports the advancement of new therapies that can address unmet medical needs.

Roles of CBER

The primary role of CBER is the regulation of biological products. This involves a comprehensive review process that assesses the safety, efficacy, and quality of biologics before they can be marketed. Additionally, CBER oversees the research and development of biologics, ensuring that it adheres to the highest scientific and ethical standards. This oversight extends to the clinical trials that test these products on human subjects, where CBER's role is crucial in protecting participants and ensuring the integrity of the data collected.

Functions of CBER

Review and Approval of Biologics: CBER reviews applications for new biological products and decides on their approval. This process includes evaluating clinical trial data, manufacturing processes, and pharma labeling to ensure that each product meets the required standards for safety and effectiveness.

Monitoring of Biologics Post-Market: After a biologic is approved and marketed, CBER continues to monitor its safety and effectiveness. This includes reviewing reports of adverse events, conducting inspections of manufacturing facilities, and, if necessary, taking action to address any safety concerns that arise.

Research to Support Regulatory Decision-Making: CBER conducts and supports research that helps inform its regulatory decisions. This research can include studies on the mechanisms of diseases, the action of biologics at the molecular level, and the development of new methods for evaluating product safety and effectiveness.