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- FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standardsThe U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
- Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence TrialsThe Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…