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” July 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2022-D-0219
- Docket Number:
- FDA-2022-D-0219
- Issued by:
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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
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).