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USA – CDER approved 50 novel drugs in 2024, record number...
Innovation Across Medical Conditions
In 2024, we approved 50 new drugs never before approved or marketed in the U.S.,
known as “novel” drugs. We also made...
Europe – MDCG 2024-8 Rev. 1 Preliminary assessment review...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
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 – « Cash Investigation ». Pénuries de médicaments : les labos font-ils...
Pour le troisième hiver consécutif, la France fait face à un phénomène inquiétant : les pénuries de médicaments. En 2023, près de 5 000 références de médicaments...
