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See the sources that passed The regulatory position is unambiguous

"An alignment with this guideline would be highly desirable for pharmaceutical companies who develop products which are intended for registration in multiple markets covering both EU and US." Echoing other stakeholders, Xellia asked FDA to ensure it harmonizes terminologies and thresholds with EMA and ICH.

In addition, it has a drug-affinity complex (DAC) attached, enhancing its half-life to up to 8 days [25, 26]