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Biologics Naming: US FDA Ponders How To Put New System In Place, While WHO Puts Hold On Pilot Study

 
• By Sue Sutter

US regulator is currently focused on prospective application of suffix-based naming system for most novel biologics and biosimilars but is still considering how best to change the names of existing products. Meanwhile, World Health Organizations announces it will not proceed 'at present' with its biological qualifier program.

FDA entrance sign 2016

As the US FDA weighs implementation of a suffix-based naming system for biologics, the World Health Organization has decided to shelve, at least for now, its own plan for a different naming convention.

Nine months after issuing a final guidance on nonproprietary naming of biological products, FDA has yet to approve a 351(a)...

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