Which organization is primarily responsible for the approval of biological products in the United States?

The Food and Drug Administration (FDA) is the primary organization responsible for the approval of biological products in the United States. This includes a wide range of products derived from living organisms, such as vaccines, blood products, and gene therapies. The FDA's Center for Biologics Evaluation and Research (CBER) specifically oversees the regulation and approval process for these biological products, ensuring they are safe, effective, and manufactured according to strict quality standards.

The role of the FDA in this regard is crucial, as it coordinates the evaluation of clinical trial data, inspects manufacturing facilities, and conducts post-marketing surveillance. By managing these responsibilities, the FDA ensures that biological products meet the necessary regulatory requirements before they can be made available to the public.

Other entities may play significant roles in public health and research—like the Department of Health and Human Services which oversees public health initiatives, the Centers for Disease Control and Prevention which focuses on disease control and prevention, and the National Institutes of Health which is primarily engaged in medical research—but they do not have the regulatory authority that the FDA possesses with regard to the approval of biological products.