Overview of FDA Drug Approval and Labeling

The U.S. Food and Drug Administration (FDA) regulates a variety of products, including medical, food, and tobacco products. Prior to the creation of the FDA, there were few protections to the public around the contents and sale of food and pharmaceuticals. Over time, legislation was passed and amended that ensured drugs and biologics undergo extensive review by multidisciplinary teams to provide assurance that marketed products are safe and effective for their intended use. The FDA-approved drug labeling is the primary tool for communicating essential information regarding the safe and effective use of a drug product. As such, providers should be familiar with the format of the prescribing information because it is a valuable source of information, particularly prior to prescribing a new drug for the first time. Although there are clinical circumstances in which off-label drug use may be warranted, prescribing drugs off-label involves a context of use that has not undergone the FDA's rigorous evaluation of the benefit-risk assessment. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology (J Allergy Clin Immunol Pract 2022;10:3051-6)

Automated summary

The U.S. FDA regulates various products to ensure their safety and effectiveness. The FDA-approved drug labeling is an important tool for conveying information about drug use. Providers should be familiar with the format of prescribing information and be cautious about off-label drug use.