Center for Biologics Evaluation and Research

Center for Biologics Evaluation and Research (CBER) is a component of the United States Food and Drug Administration (FDA) responsible for regulating biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER's mission is to ensure the safety, purity, potency, and effectiveness of biological products, including vaccines, blood and blood products, and cellular and gene therapies, among others, available to the public.

Overview

The Center for Biologics Evaluation and Research (CBER) was established to oversee the regulation of biological products, which are derived from living organisms and their cells. These products are used in the prevention, diagnosis, and treatment of various diseases and conditions. CBER's regulatory oversight extends from the preclinical stages of product development through clinical trials and into post-market surveillance to ensure the continued safety and efficacy of these products.

Regulatory Functions

CBER performs several key regulatory functions, including:

• Review and Approval of Biological Products: CBER reviews New Drug Applications (NDAs) and Biologics License Applications (BLAs) for biological products. This process involves evaluating clinical trial data to ensure that the product is safe and effective for its intended use.

• Inspection and Compliance: CBER inspects manufacturing facilities to ensure compliance with regulatory standards for the production and testing of biological products. This includes ensuring adherence to Good Manufacturing Practices (GMPs).

• Research and Development: CBER conducts and supports research related to the development, manufacture, and evaluation of biological products. This research helps inform regulatory policy and decision-making.

• Policy and Guidance Development: CBER develops policies, guidelines, and regulations to clarify regulatory requirements for industry and to ensure the protection of public health.

• Post-Market Surveillance: CBER monitors the safety of biological products after they are on the market through systems like the Vaccine Adverse Event Reporting System (VAERS) and the Blood Product Deviation Reporting system.

Areas of Regulation

CBER regulates a diverse range of biological products, including:

• Vaccines: CBER is responsible for the regulation of vaccines against infectious diseases.
• Blood and Blood Products: This includes regulation of blood donations and blood components intended for transfusion or for the manufacture of pharmaceuticals.
• Cellular and Gene Therapies: CBER oversees therapies that involve the manipulation of cells or genetic material for the treatment of diseases.
• Tissue and Tissue Products: This includes the regulation of human tissues used for transplantation.
• Allergenics: Products used for the diagnosis and treatment of allergic diseases and conditions.

Challenges and Future Directions

The field of biologics is rapidly evolving with advancements in science and technology, such as gene editing and personalized medicine. CBER faces the challenge of adapting regulatory frameworks to accommodate these innovations while ensuring the safety and efficacy of emerging biological products. The center is also involved in international harmonization efforts to align regulatory standards and practices globally.

See Also

• Food and Drug Administration
• Biologics License Application
• Good Manufacturing Practices
• Vaccine Adverse Event Reporting System

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