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USP Comments on FDA Biologics Naming Draft Guidance

The naming approach proposed is a departure from well-established scientific naming principles

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By: Kristin Brooks

Managing Editor, Contract Pharma

The United States Pharmacopeial Convention (USP) has commented on the FDA draft guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry”, which describes FDA’s proposal that all biologics bear a nonproprietary name that includes a manufacturer-specific FDA-designated suffix. “We understand the naming approach for biologics in the Draft Guidance reflects FDA’s interest in preventing inadvertent substitution of and facilitating pharmacovigila...

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