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

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

Collection:
Health Policy and Services Research
Contributor(s):
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Language(s):
English
Format:
Text
Subject(s):
Biological Products -- administration & dosage
Drug Dosage Calculations
Drug Industry
Drug Labeling
Drug Packaging
Government Regulation
Injections -- standards
Prescription Drugs -- administration & dosage
Product Labeling
Product Packaging
United States
Genre(s):
Guideline
Technical Report
Abstract:
This guidance provides recommendations to assist applicants in incorporating information into proposed human prescription drug labeling for injectable drug products when: (1) Dosing for the drug product is based on weight or body surface area (BSA), (2) The drug product is available in a range of strengths in ready-to-use containers, and (3) The entire drug content of the ready-to-use container(s) is intended to be administered to a patient. For the purposes of this guidance, this practice is referred to as dose banding. This guidance applies to proposed labeling in a new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 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. This guidance does not apply to abbreviated new drug applications (ANDAs), which are generally required to have the same labeling as the reference listed drug (RLD). This guidance also does not apply to BLAs submitted under section 351(k) of the PHS Act; the labeling of biosimilar and interchangeable products generally incorporates relevant data and information from the FDA-approved labeling of the reference product, with certain modifications. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (7 pages))
NLM Unique ID:
9918732188806676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918732188806676