USP Backs Down From Biologic Monograph Naming Plan Amid US FDA Objections
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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Generic applicants can request monograph changes while FDA assessment is ongoing.
In a letter to Senate HELP Committee chairman Sen. Lamar Alexander and ranking member Sen. Patty Murray, USP and other stakeholders are calling for the removal of language that would exclude biological products from requirements to follow USP quality standards.
'This is important for our own pharmacovigilance,' US FDA commissioner says. 'We still have an open question on whether or not we’re going to apply a suffix or change also the branded company’s name as well.'