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Center for Biologics Evaluation and Research (CBER) is one of the key centers within the Food and Drug Administration (FDA) that regulates Biological products. CBER regulates biological products as per the Public Health Service (PHS) Act, which emphasizes the importance of control over manufacturing of the products. As most of the biological products meet the definition of drugs, CBER also regulates those drugs as per Federal Food, Drug and Cosmetic Act (FD&C Act). In similar ways, CBER also regulates some of the medical devices which are used to produce Biologics.

The CBER creates an awareness among people to promote safe and proper use of biological products. The center is responsible for assuring the safety, purity, and effectiveness of biological products for human use. Even after the biological product is approved CBER plays a major role in monitoring the safety and efficiency of the approved biological product.

As similar to any new drug approval process, after laboratory and animal testing a biological product goes through clinical trials in humans through an Investigational New Drug (IND) and following which, if the studies seems to be safe and effective, the data is submitted to CBER in the form of Biological License Application (BLA) for necessary approvals and marketing. The CBER inspects manufacturing products before the approvals. Depending on the requirement, CBER conducts conformity tests, laboratory research as per the necessary Regulatory standards to validate the safety, purity, and effectiveness of biological products.

List of Products which CBER regulates:

  • Gene Therapy
  • Blood
  • Allergenics
  • Vaccines
  • Human Tissue and Cellular Products
  • Xenotransplantation Products
  • Devices

As the regulations are evolving, keeping abreast with CBER’s new Regulatory standards for biological products might be difficult for manufacturers. To get customized information and Regulatory support regarding the approach towards CBER regulations, speak to our Biologics Regulatory Affairs experts. Reach us at sales@freyrsolutions.com.