The U.S. Food and Drug Administration (FDA) has recently issued a new guideline titled “Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” Guidance for Industry” and was recently published in October 2023. The guideline represents the current thinking of the FDA on labeling for dosing based on weight or body surface area (BSA) for ready-to-use containers.
Understanding Dose Banding
Dose banding is a practice where dosing for the drug product is based on weight or 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.
Purpose of the Guideline
The primary purpose of the FDA guideline is to assist applicants when dosing is based on weight or BSA, and the drug product comes in a range of strengths within ready-to-use containers. The guideline aims to ensure that the entire drug content in these containers is administered to the patient.
The FDA’s guidance on dose banding for ready-to-use containers includes several recommendations:
- Dosage and Administration Section: Display dose banding information and previously approved recommended dose. Include details on selecting the right ready-to-use container(s) based on the patient’s weight or BSA.
- Clinical Pharmacology Section: Provide clinical/scientific information supporting dose banding when applicable. Detail the maximum difference between the previously approved and proposed product’s dose in the Pharmacokinetics subsection.
- Information on doses: Offer information on doses using a range of ready-to-use containers, including the maximum acceptable differences between the recommended dose of the previously approved drug product and the dose based on available strengths of the ready-to-use containers.
- Recommendations for situations when dose falls outside of dose range: Provide recommendations for situations when the dose based on weight or BSA falls outside of the dose range for which the ready-to-use containers are supplied.
Impact of dose banding guidance on drug manufacturers
The FDA’s guidance on dose banding for injectable drug products could have several implications for drug manufacturers:
- Data and Evidence: Manufacturers may need to provide sufficient data and evidence to validate the safety and efficacy of proposed dose banding ranges for their injectable drug products.
- Labeling Updates: They may need to update their labeling to include clear instructions on how to select and administer the appropriate ready-to-use container(s) based on the patient’s weight or BSA, as well as the maximum acceptable differences between the exact weight- or BSA-based dose and the dose based on dose banding.
- Simplification and Reduction: Dose banding could simplify the preparation and administration of their injectable drug products and reduce drug waste and medication errors.
Application of Guidance
The guidance is intended to assist applicants in incorporating dose banding information into the proposed drug labeling in a new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and in a biologics license application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act), or a supplement to one of these approved applications. However, it does not apply to abbreviated new drug applications (ANDAs) or BLAs submitted under section 351(k) of the PHS Act.