US FDA's Stein: 'Cognitive Dissonance' Exists Between Review Divisions In Regulation Of Biosimilars

 
• By Michael Cipriano

US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.

US FDA divisons have not yet achieved a consistent approach for regulating biosimilars, OND Director Peter Stein Says

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