Understanding FDA User Fee Programs: PDUFA, BsUFA, and Their Impact on Patient Access to Therapies

The purpose of this educational activity is to enhance pharmacists understanding of how FDA user fee programs—particularly the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA)—expedite the drug review process and impact patient access to safe and effective therapies. Participants will learn how these programs operate, how they are funded, and their impact on public health and patient care outcomes.