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News
Date Posted
News Title
2024/01/03
US: FDA CGT draft guidance focuses on potency assurance strategy
2024/01/02
Europe: MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024
2023/12/29
US: FDA finalizes guidances on RWD in regulatory submissions, assessing registries
2023/12/28
Europe: MDCG responds to new questions on MDR, IVDR rules for importers and distributors
2023/12/27
Australia: Promise Pilot Pathway: Access work-sharing for priority prescription medicine applications
2023/12/26
US: FDA proposes master control trial guidance that goes beyond COVID-19
2023/12/26
Europe: Wearable technology to be offered to thousands with type 1 diabetes in UK
2023/12/22
US: FDA proposes updated medtech RWE guidance
2023/12/21
Europe: Artificial intelligence workplan to guide use of AI in medicines regulation
2023/12/20
Asia: Singapore’s HSA details changes to eCTD implementation
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