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La FMH fait sienne la recommandation du Conseil médical et scientifique de la NHF sur les risques relatifs aux essais cliniques en thérapie génique

Le 6 décembre 2018, le MASAC (Conseil consultatif médical et scientifique de la NHF) a rendu publique la recommandation n° 254 intitulée « MASAC Document Regarding Risks of Gene Therapy Trials for Hemophilia ».

Aussi disponible en : English Español

La recommandation du MASAC dresse un état des lieux des différents aspects qu’il convient de garder à l’esprit s’agissant des essais cliniques en thérapie génique. Elle soutient de tels essais cliniques chez l’homme tout en soulignant l’importance d’identifier et de réduire les risques encourus par les patients, de faire face aux risques encore inconnus liés au processus des essais cliniques et de veiller à maintenir une communication ouverte et continue sur les avancées enregistrées avec les membres de la communauté concernée par l’hémophilie.

Le Conseil consultatif médical de la FMH fait sienne la recommandation intitulée « MASAC Document Regarding Risks of Gene Therapy Trials for Hemophilia » publiée le 6 décembre 2018.

Veuillez cliquer ici pour lire la recommandation publiée par le MASAC.

Pour lire les observations de la FMH sur le document « Draft Guidance for Industry: Human Gene Therapy for Hemophilia » adressées à la Food and Drug Administration (FDA) américaine, veuillez cliquer ici (uniquement en anglais).

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