Your Article Summary
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.
Today in Regulatory Issues...keeping you current
Receive free subspecialty "5-minute updates" via email
Tricare contracts may be re-bid after losing plans protest
American Medical News , 11/25/09
GSK Regulatory Update: Avodart
GlaxoSmithKline, 11/24/09
Baytubes carbon nanotubes in marine coatings help reduce frictional resistance
BayNews International, 11/24/09
Article Search
Sponsor


See Latest Articles


