Understanding the Regulatory Pathways Used to Develop, Evaluate, Authorize, and Approve New Drugs and Vaccines in the United States.

This article focuses on the regulatory oversight of drugs and vaccines by the U.S. Food and Drug Administration (FDA), specifically the roles of its two main centers: the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). CDER primarily regulates drugs, including most therapeutic biologics such as monoclonal antibodies, while CBER oversees vaccines, blood products, and certain biologics related to disease prevention. The article outlines the clinical trial phases required for FDA approval, the advisory committees that provide expert guidance, and the processes for expedited review and Emergency Use Authorization during public health emergencies. It also describes the role of the Advisory Committee on Immunization Practices (ACIP) in developing vaccine recommendations and the federal Vaccines for Children program that supports vaccine access.