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Biosimilar User Fee Talks Begin With Industry Negotiating Amongst Itself

 
• By Derrick Gingery

FDA asks negotiators from the four industry groups to coordinate proposed changes as BsUFA renewal talks get underway.

Before industry trade groups can start negotiating with FDA on reauthorization of the biosimilar user fee program in earnest, they may first have to compromise on a common set of changes amongst themselves.

As part of the first negotiating session, the industry representatives present, which included four representatives from the Pharmaceutical Research and...

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More from North America

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• By Eliza Slawther and Sarah Karlin-Smith

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US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
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