Azar: International Regulatory Harmonization Will Create More Stable Generic Markets
HHS secretary tells AAM that "fundamental" changes require legislation, but "FDA and our peers are exploring new potential areas for alignment."
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Biosimilar Bridging Study Waivers: Public Health Prerogative Or Trade Secret ‘Taking’?
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At US Generic Association Annual Meeting, Worries About Sustainability
ANDA sponsors fret price erosion – and potential changes to 180-day exclusivity.