Uses of drugs not described in the package insert (off-label uses)

Title

Uses of drugs not described in the package insert (off-label uses)

Creator

Committee on Drugs - American Academy of Pediatrics

Publisher

Pediatrics

Date

2002

Subject

Child; Humans; United States; United States Food and Drug Administration; Prescriptions; Organizational Policy; Drug; Clodronate; Drug Approval; Societies; Adverse Drug Reaction Reporting Systems/legislation & jurisprudence; Drug Labeling/legislation & jurisprudence; Internet/legislation & jurisprudence; Medical/standards; Pediatrics/legislation & jurisprudence/standards; Physician's Practice Patterns/legislation & jurisprudence

Description

New regulatory initiatives have been designed to ensure that new drugs and biologicals include adequate pediatric labeling for the claimed indications at the time of, or soon after, approval. However, because such labeling may not immediately be available, off-label use (or use that is not included in the approved label) of therapeutic agents is likely to remain common in the practice of pediatrics. This policy statement was written to address questions practitioners have regarding off-label use. The purpose of off-label use is to benefit the individual patient. Practitioners may use their professional judgment to determine these uses. Practitioners should understand that the Food and Drug Administration does not regulate off-label use.
2002

Rights

Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).

Type

Journal Article

Citation List Month

Backlog

Pages

181-183

Issue

1

Volume

110

Citation

Committee on Drugs - American Academy of Pediatrics, “Uses of drugs not described in the package insert (off-label uses),” Pediatric Palliative Care Library, accessed December 8, 2021, https://pedpalascnetlibrary.omeka.net/items/show/12657.

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