Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”

July 21, 2022

Draft Guidance

July 2022

This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a biologics license application (BLA) submitted under the Public Health Service Act (PHS Act), or a supplement to one of these approved applications when an applicant proposes to develop ready-to-use containers with a range of different strengths and seeks to incorporate dose banding information into the prescribing information of the proposed drug product based on dosing information of a previously approved drug product that is based on weight or body surface area (BSA).

Download Draft Guidance Document
Read the Federal Register Notice

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.




FDA North America Close-up and exploded view of the skin.

June 21, 2022

Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures

June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...

Read the Full Article
FDA North America An analog balancing scale.

July 20, 2022

FDA Draft Guidance for Industry, Evaluation of Therapeutic Equivalence

FDA Draft Guidance July, 2022 As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry,...

Read the Full Article
FDA North America Computer generated rendering molecules, cells, and DNA structures.

June 16, 2022

Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation...

Read the Full Article