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Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”

July 21, 2022

Draft Guidance

July 2022

This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a biologics license application (BLA) submitted under the Public Health Service Act (PHS Act), or a supplement to one of these approved applications when an applicant proposes to develop ready-to-use containers with a range of different strengths and seeks to incorporate dose banding information into the prescribing information of the proposed drug product based on dosing information of a previously approved drug product that is based on weight or body surface area (BSA).

Download Draft Guidance Document
Read the Federal Register Notice

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FDA North America NDA Drug Body Surface Area New Drug Application and Cosmetic Act Agency Alerts Biologics License Application BLA FD&C Act BSA Regulatory Sciences



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