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BsUFA III Talks Could Move Cloud-Platform Goals Forward

Executive Summary

US FDA wants to use biosimilars for a demonstration of cloud-based technology, an idea mentioned to increase the use of real-time review and enhance data analysis.

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Real-World Evidence Under Consideration For Use In Interchangeable Biosimilars Applications

US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.

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