1. Pink Sheet

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

 
• By Sue Sutter

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.

Stop barrier

Facing strong but divergent opposition from the US FDA and other stakeholders, USP has shelved a proposal aimed at aligning its biologic product monographs with the agency’s suffix-based naming system.

On April 27, USP announced it will not move forward with a proposed one-sentence revision to its General Notices and Requirements aimed at ensuring consistency between its monograph system and...

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