FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway
FDA Law Blog
JANUARY 12, 2025
Of note, the 2004 accelerated approval of natalizumab (Tysabri) for relapsing-remitting multiple sclerosis was based on the Kurtzke Expanded Disability Status Scale (EDSS) score at one-year; two-year EDSS data were used to verify and describe the clinical benefit for conversion to traditional approval.
64 
Let's personalize your content