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BsUFA Suggestions From Sponsors Sound Easy, But Changes May Be Difficult For US FDA

 
• By Derrick Gingery

Biosimilar sponsors want meeting and assessment best practices implemented across divisions, but the FDA says that may be difficult and time-consuming.

Woman holding elephant
With no assessment team focused solely on biosimilars, best practices for the applications must be implemented throughout OND. • Source: Shutterstock

Changes to the US FDA’s biosimilar application assessment process suggested by a consulting firm and industry seem small, but implementation within the agency could be a challenge.

Adjustments such as providing sponsors advance notice when information requests will be sent were suggested during a meeting to discuss...

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