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BsUFA III Talks Could Move Cloud-Platform Goals Forward

 
• By Derrick Gingery

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.

Negotiators also discussed BsUFA finances and regulatory science during two recent sessions. • Source: photo illustration

Biosimilars could help the US Food and Drug Administration adopt cloud-based technology upgrades for clinical trial and other data analysis.

A cloud-based technology demonstration project was proposed for the biosimilar user fee program’s upcoming reauthorization, according to minutes of...

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Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
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More from Biosimilars & Generics

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
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EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

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