Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Exemption from Bioequivalence Studies Adopted as New Topic at ICH Meeting in Lisbon; Could Affect Generics as Well
“Biowaivers” that would allow drug makers to skip conducting bioequivalence studies of oral agents if certain conditions are met was adopted as a new topic (M9) at a meeting of the International Council for Harmonization of Technical Requirements for Registration…
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REGULATORY
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