Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling
A prescription drug’s package insert (or labeling) is a document written by the manufacturer and first approved by the US Food and Drug Administration (FDA) as part of the drug approval process. The labeling describes 1 or more indications for which the drug has been approved and provides detailed information about the approved use, including dosage, frequency of administration, clinical study data, and safety issues.
The labeling is not static; it evolves as more information is learned about the drug after the initial regulatory approval. Most labeling changes are initiated by manufacturers. For example, if a drug shows efficacy in additional indications, manufacturers may file an efficacy supplement with the FDA to add a new indication to the labeling. The FDA similarly reviews and approves efficacy supplements that address other types of labeling changes, such as changes in dose or dosing regimen, new comparative efficacy claims, and changes to the indicated population.