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USA – FDA proposes to modernize guidance on sex, gender in...
The US Food and Drug Administration (FDA) is proposing to update two guidance documents that clarify terminology around sex and gender of clinical trial...
USA – FDA finalizes guidance on reporting medical device shortages
The US Food and Drug Administration (FDA) issued finalized guidance on its requirements for notifying the agency of potential medical device shortages during 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 – Dépakine : la justice confirme que l’Etat est en...
La cour administrative d’appel de Paris a confirmé mardi que l'État avait une part de responsabilité dans l'"insuffisance d'information" donnée aux patients et aux médecins sur...
