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

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-prescription-drug-and-biological-products-labeling-dosing-based-weight-or-body-surface-area?utm_medium=email&utm_source=govdelivery Today, the U.S. Food and Drug Administration issued a final guidance titled, “Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers – “Dose Banding.” This final guidance provides recommendations to assist applicants in incorporating information into human prescription drug labeling on how to dose patients with drugs that have weight- or body surface area-based doses when using ready-to-use containers offering a range of strengths (for example, as provided in pre-mixed infusion bags). The recommendations outlined in the final guidance are intended for applicants seeking to include information in labeling under a supplement to an existing new drug application (NDA) or 351(a) biologics license application (BLA) or for an original NDA or 351(a) BLA.