ipl-logo

Off-Regulatory Bodies: A Case Study

303 Words2 Pages
The principal objective of the drug regulatory bodies is to make sure that medicines are marketed only after appropriately scrutinized for their efficacy, safety and quality. Once the approval is granted, however, FDA (Food and Drug Administration) has a minimal role in determining whether drugs are prescribed for their approved uses as indicated on the product labels. Off-label drug use refers to the prescription of licensed drugs for clinical indications or in a manner different from that approved by the drug regulatory body. Off-label drug use takes many forms like use of drugs for an unapproved indication, in a patient population, through a route of administration, or with a dose not specified in the approved labelling (22).
Off-label
Open Document