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Europe – A common EU approach to data transparency in medicine...
EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and...
USA – FDA updates GUDID final guidance
The US Food and Drug Administration (FDA) issued an updated final guidance on Tuesday addressing the submission of unique device identifiers (UDIs) to the...
Europe – MDCG 2022-3 rev.1 – Verification of manufactured class D...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes
the requirements for notified bodies involved in the conformity assessment of applicable classes of...
France – Covid-19 : une étude fondatrice défendue par Didier Raoult...
Après plus de quatre ans de controverses, l’étude fondatrice, notamment signée par Didier Raoult, sur l’usage de l’hydroxychloroquine contre le Covid-19 a été invalidée,...
