Individual Endpoints Pose Challenge For US FDA In Review Of Rare Disease Drug

07 Jan 2020

FDA reviewer describes difficulties in reviewing application for Mepsevii for Sly syndrome; the experience provides perspective for other companies seeking to use novel endpoints.

Male red plastic toy businessman silhouette wooden figure background closeup. Manipulate work recruitment transfer labour inspectorate experience exchange man hr worker subordination human concept — FDA faced challenges in review of rare disease drug Mepsevii.

Individual Endpoints Pose Challenge For US FDA In Review Of Rare Disease Drug

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