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.
PDUFA covers new drugs and original biologics, BsUFA covers biosimilars, and GDUFA covers generic drugs. Each user-fee act funds FDA review of its application type and sets the goal dates the agency commits to meeting for that review.
FAQ
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.