USP updates guidelines for monograph submissions


June 19, 2007

A new version (Version 3, January 2007) of USP's Guideline for Submitting Requests for Revision to the USP–NF (Revision Guideline) is now available. The purpose of the Revision Guideline is to help Sponsors (e.g., manufacturers) effectively and efficiently prepare submissions for new monographs and revisions to existing monographs for publication in the USP–NF. Highlights of Version 3 include incorporation of ICH terminology, an explanation about flexible monographs, revised templates for drug substances and products, and new dosage form templates.