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UK – MHRA approves first UK treatment for congenital thrombotic thrombocytopenic...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (12 May 2025) approved rADAMTS13 (ADZYNMA), the first UK treatment to treat congenital thrombotic...
Australia – Understanding regulatory requirements for in vitro diagnostic (IVD) companion...
The purpose of this guidance is to outline the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or...
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 – Papillomavirus (HPV) : le rattrapage vaccinal recommandé chez les...
L’infection à papillomavirus humains (HPV, Human Papilloma Virus en anglais) est extrêmement courante, surtout au début de la vie sexuelle. Même si ces virus sont...
