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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

The US Food and Drug Administration needs to overcome what Office of New Drugs (OND) director Peter Stein described as a "cognitive dissonance" among the various review divisions to implement a consistent framework for the development and review of biosimilar products.

Biosimilar stakeholders have made a strong push for the FDA to implement a consistent regulatory approach that eases requirements for what they feel are unnecessary clinical trials for development

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