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

Dose banding standard deviation graph.

Draft Guidance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Download Draft Guidance Document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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TAGS: 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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