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USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area

Earlier today (2 October 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research and Oncology Center of Excellence released a final guidance "Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”".

A dose band is a method used in pharmaceuticals and medical settings to simplify the dosage of medications, particularly chemotherapy drugs. This approach involves rounding doses to specific predetermined levels or "bands" rather than calculating each dose individually based on a patient's body surface area or weight.

The goal of dose banding is to streamline the drug preparation process, reduce the risk of calculation errors, and improve the efficiency of drug administration while maintaining patient safety and efficacy.

This guidance provides recommendations to assist applicants in incorporating information into proposed human prescription drug labeling for injectable drug products when:

  • Dosing for the drug product is based on weight or body surface area (BSA),

  • The drug product is available in a range of strengths in ready-to-use containers, and

  • The entire drug content of the ready-to-use container(s) is intended to be administered to a patient.

In this guidance, recommendations are provided for how to incorporate dose banding information into the labeling of injectables that seek approval under subsection 505(b) of the FD&C Act (21 U.S.C. 355(b)), section 351(a) of the PHS Act (42 U.S.C. 262(a)), or in 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 the dosing information of a previously approved drug product that is based on weight or BSA.

Click this LINK to know more in detail on the recommendations on the labeling etc related to Dose banding.


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