Off-Label Use

Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company’s New Drug Application (NDA) for data from clinical trialsto see if the results support the drug for a specific use or indication. If satisfied that the drug is safe and effective, the drug’s manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug’s label. More detail is included in the drug’s package insert.


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