FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|September 18, 2019
Harmonization Efforts by Pharmacopoeias and Regulatory Agencies (PDF)
Author(s)J. Mark Wiggins, Joseph A. Albanese
The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.
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