FDA finalizes guidance on dose banding for injectables
The US Food and Drug Administration (FDA) has finalized its guidance on dose banding to assist sponsors in labeling ready-to-use containers for injectable drug products. With this guidance, FDA aims to eliminate drug waste from single-dose vials by shifting toward exact weight or body surface area-based doses.The final guidance, which was published on 2 October 2023, is intended for sponsors seeking to update the labeling information in a supplement to an existing new drug application (NDA) or biologics license application (BLA) or for new NDAs and BLAs.
Dose banding refers to dosing based on weight or body surface area (BSA), drug products that are available in a range of strengths in ready-to-use containers, or instances in which the entire drug content of the ready-to-use container is intended to be administered to a patient.
“The availability of a drug product in a range of different strengths in ready-to-use containers (for example, pre-mixed infusion bags) that could be administered in their entirety also may reduce significant drug waste from single-dose vials used for exact weight- or BSA-based dosing and would eliminate the need to calculate and extract partial doses from vials,” the guidance states.
The final guidance contains minor revisions from a draft issued in July 2022 (RELATED: Dose banding: FDA aims to reduce drug waste in new labeling guidance, Regulatory Focus 20 July 2022). FDA said it “considered comments received on the draft guidance as it developed the final guidance. Changes from the draft guidance are primarily intended to improve clarity.”
For example, FDA acceded to a request to provide more information on the use of model-informed drug development (MIDD) approaches in determining dosing for ready-to-use containers. It refers applicants to its February 2022 guidance on population pharmacokinetics and its May 2003 guidance on exposure-response relationships in study design, data analysis and regulatory applications.
Sponsors that want to include dose banding information “need to provide adequate data to support the safety and efficacy of the proposed ranges.” The data should also “explain and justify the acceptability of the differences between the proposed to-be-administered dose in the ready-to-use containers (i.e., dose banding) and the exact weight- or BSA-based dose from the approved drug product in single-dose vials,” FDA wrote.
The evidence used to set acceptable ranges to support dose banding “may depend on the nature of the dose- or exposure-response of the drug, therapeutic index, and pharmacokinetic characteristics of the drug product,” according to the guidance.
Dose banding information should be included in the “dosage and administration” section of the labeling along with the previously approved recommended dose based on weight or BSA. Additionally, the clinical or scientific information supporting the use of dose banding may be included in the “Clinical Pharmacology” section.
The final guidance also includes an appendix with a fictitious example of labeling that incorporates dose banding information for a ready-to-use container.
FDA final guidance
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