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GUIDANCE DOCUMENT

Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” October 2023

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2022-D-0219
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance provides recommendations for incorporating dose banding information into the labeling of an injectable drug product that is seeking approval through a new drug application submitted under section 505(b) of the FD&C Act (21 U.S.C. 355(b)), a biologics license application submitted under section 351(a) of the PHS Act (42 U.S.C. 262(a)), or a supplement to one of these approved applications.  The recommendations and examples in this guidance are relevant to situations in which an applicant (1) proposes to develop ready-to-use containers with a range of different strengths for an injectable drug product and (2) seeks to incorporate dose banding information into the prescribing information based on dosing information of a previously approved drug product that is based on weight or BSA.

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All written comments should be identified with this document's docket number: FDA-2022-D-0219.

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