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FDA Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers – “Dose Banding” (from Catapult’s regulatory round-up – October 2023)

This guidance provides recommendations to assist applicants in incorporating information into proposed human prescription drug labelling for injectable drug products and is relevant to situations when:

  • Dosing for the drug product is based on weight or body surface area (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.

This guidance applies to proposed labelling 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.

Published on the 6th of November 2023. read Catapult’s entire regulatory round-up here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (21 mai 2024). FDA Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers – “Dose Banding” (from Catapult’s regulatory round-up – October 2023). ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/11ozu


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