FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway
FDA Law
JANUARY 12, 2025
Surrogates are generally biomarkers, such as laboratory, radiographic, imaging, physical, or other measures that are thought to predict benefit but are not inherently measures of clinical benefit. one that is known to predict clinical benefit and could support traditional approval); reasonably likely surrogates ( e. ,
64 
Let's personalize your content