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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 Manufacturers of America, four from the Biotechnology Innovation Organization, two...

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