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USP Backs Down From Biologic Monograph Naming Plan Amid US FDA Objections

Executive Summary

Proposed change was aimed at protecting monograph-covered products subject to March 2020 'transition provisions,’ but agency’s objections went to the heart of the monograph system; other stakeholder groups said proposed change would amount to an endorsement of FDA's flawed and unjustified suffix-based naming system for biologics.

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