BsUFA III Talks Begin With Regulatory Science Disagreement
Brand trade group negotiators don’t support a biosimilar regulatory science proposal from the biosimilar and generic drug trade groups.
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US Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement
Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.
Former FDA official says the pathway is needed to avoid wasted sponsor time and effort.
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.