The FDA funds much of its review work through user-fee acts, each covering a different product type and each setting fee and review-timeline goals (the 'goal date').
PDUFABrand / novel drugs & biologics (NDA/BLA)
BsUFABiosimilars
GDUFAGeneric drugs (ANDA)
For catalyst investors, PDUFA dates are the headline events — novel-drug approvals move stocks most. BsUFA (biosimilar) and GDUFA (generic) goal dates matter mainly for the companies whose revenue they threaten or create. Learn the basics: what is a PDUFA date.
What's the difference between PDUFA, BsUFA and GDUFA?
PDUFA covers brand/novel drugs and biologics, BsUFA covers biosimilars, and GDUFA covers generic drugs. Each sets FDA user fees and review-timeline goals for its product type.