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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The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
ANDA user fee goals likely would have to be reconfigured to account for business days and still maintain the intended length of time.
An early meeting option is needed so sponsors can discuss clinical trial endpoints and similar issues before analytic data is available, industry tells the US FDA.