2023-21558: Human Prescription Drug and Biological Products-Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers-“Dose Banding”; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--`Dose Banding.' " The guidance is intended to assist applicants in incorporating dose banding information, based on dosing information of a previously approved drug product that is based on weight or body surface area (BSA), into the proposed labeling of injectable drug products that are the subject of certain marketing applications submitted to FDA. This guidance finalizes the draft guidance of the same title issued on July 21, 2022.
The agency’s own summary, as published.
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