Examination of the Relationship Between Oncology Drug Labeling Revision Frequency and FDA Product Categorization Berlin RJ - Accelerated approval products are approved based on surrogate endpoints; this approval process anticipates subsequent labeling refinement. Priority review products, however, are approved through a process that is ostensibly as rigorous as traditional review. Their higher than expected label revision rate may suggest deficiencies in the FDA’s current priority review evaluation processes. [more...]
