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Examination of the Relationship Between Oncology Drug Labeling Revision Frequency and FDA Product Categorization
American Journal of Public Health, 07/01/09

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.


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