What is the typical FDA approval timeline for a new drug?

From IND filing to FDA approval, the median timeline is 10-12 years. Phase 1 averages 1-2 years, Phase 2 takes 2-3 years, Phase 3 runs 3-4 years, and the NDA/BLA review period is 10-12 months (6 months with Priority Review). Breakthrough Therapy designation can compress timelines by 2-3 years through rolling review and intensive FDA engagement.