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FDA review (Review programmes (Standard, Fast track, Accelerated, Priority…
FDA review
Review programmes
Standard
Fast track
Accelerated
Priority
Breakthrough
Safety and efficacy
Preclinical
Clinical
Post marketing
lessons learned
TPP
EMA comparison
New drug mAb
Oncomab name
Meetings and reports
Phase 1-3 and post marketing
Melanoma
Stats and disease stages
Metastatic Stage 4