A biologic is a medical product made from living organisms, such as vaccines or gene therapies, used to prevent, treat, or diagnose diseases. The Food and Drug Administration (FDA) interacts with sponsors throughout the drug development and approval process in order to guide and regulate the sponsor’s approach to demonstrating safety and efficacy of their product. Official review of a new drug’s safety and effectiveness only begins after clinical trials have been concluded, with the submission of a New Drug Application, or NDA for a drug or a Biologics License Application (BLA) for a biologic. These documents contain all of the data that researchers have gathered about the product through clinical trials, plus manufacturing, labeling, biological, and chemical information. The Center for Drug Evaluation and Research (CDER; for most new drugs and some biologics) or the Center for Biologics Evaluation and Research (CBER; for biologics not regulated by CDER) use this information to determine whether or not the sponsor has demonstrated that the product is safe and effective.