The following is the summary of  “Overview of FDA Drug Approval and Labeling” published in the December 2022 issue of Allergy and Clinical Immunology: In Practice by Clarridge, et al.

The Food and Drug Administration (FDA) of the United States oversees regulating a wide range of products, including those in the medical, food, and tobacco industries. Before the Food and Drug Administration was established, there were few safeguards in place to protect the general people regarding the composition of food and the distribution of pharmaceuticals. 

Legislation has been enacted and revised over time to ensure that drugs and biologics are subjected to exhaustive review by teams of experts from various fields. This ensures that products that are brought to market are both safe and effective for the purpose for which they were designed. The drug labeling that the FDA has approved is the principal instrument that is used to communicate vital information regarding the secure and efficient use of a drug product. As a result of this, healthcare providers ought to be familiar with the structure of the prescription information because it is a vital source of knowledge, especially in the moments leading up to the first time they prescribe a new medication. 

Although there are clinical situations where the use of off-label pharmaceuticals may be acceptable, prescribing drugs off-label includes a context of use that has yet to be subjected to a thorough review of the benefit-risk assessment by the Food and Drug Administration (FDA).