FDA Issues Draft Guidance for Industry, Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers– Dose Banding: Drug Information Update

CENTER FOR DRUG EVALUATION AND RESEARCH DIVISION of DRUG INFORMATION Your source for the latest drug information. Know the moment it happens. FDA Issues Draft Guidance for Industry, Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers– Dose Banding  Today, the U.S. Food and Drug Administration issued a draft guidance titled, Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers – Dose Banding. This draft guidance provides recommendations to assist applicants in incorporating information into human prescription drug labeling on how to dose patients with drugs that have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   The recommendations outlined in the draft guidance are intended for applicants seeking to include information in labeling under a supplement to an existing new drug application (NDA) or 351(a) biologics license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.   For information on the draft guidance and how to comment, please see the Federal Register Notice.   This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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