|
The Center for Biologics Evaluation and Research (CBER) regulates biological products. Current authority for this responsibility resides in Section 351 of the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.
CBER is committed to advancing the public health through innovative regulations that ensure the safety, effectiveness and timely delivery to patients of biological products. The mission of CBER is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, tissue, allergenics and biological therapeutics.
CBER is responsible for ensuring:
- the safety of this nation's entire blood supply and the products derived from it;
- the production and approval of safe and effective childhood vaccines, including any future AIDS vaccines;
- the proper oversight of human tissue for transplantation;
- an adequate and safe supply of allergenic materials and anti-toxins;
- the safety and efficacy of biological therapeutics, including an exciting new array of biotechnology-derived products used to treat diseases such as cancer and AIDS.
Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms). Most biologics are complex mixtures that are not easily identified or characterized, and many biologics are manufactured using biotechnology. Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments
available.
CBER's review of new biological products, and for new indications for already approved products, requires evaluating scientific and clinical data submitted by manufacturers to determine whether the product meets CBER's standards for approval. After a thorough assessment of the data, CBER makes a decision based on the risk-benefit for the intended population and the product's intended use.
Although medical products are required to be safe, safety does not mean zero risk, since all medical products are associated with some level of risk. A safe biological product is one that has reasonable risks, given the patient's condition, the magnitude of the benefit expected, and the alternatives available. The choice to use a biological product involves balancing the benefits to be gained with the potential risks. CBER is committed to a product approval process that maximizes the benefits and minimizes the risks to patients of the biological product.
|
