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UK – NICE recommends Sogroya for growth hormone deficiency in children
The National Institute for Health and Care Excellence (NICE) has recommended Sogroya (somapacitan injection) for children aged 3 to 17 years with paediatric growth...
USA – FDA final guidance adds more details to Q-Sub program
The US Food and Drug Administration has finalized an updated guidance on its Q-Submissions program that allows medtech companies to engage with regulators early...
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...
International – Chikungunya : Mayotte est passée en phase d’épidémie, annonce...
L’île de Mayotte est passée en phase d’épidémie pour le chikungunya, avec une accentuation marquée de cette maladie virale transmise par les piqûres de moustiques infectés,...
