Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) establishes how regulated industry fees support the human drug review program at the Food and Drug Administration (FDA) and associated Agency performance goals, programs and processes. The law must be renewed every five years, including a negotiation between industry and the FDA and reauthorization of the law by the U.S. Congress. This session will explore the changes we can anticipate during PDUFA VIII (effective Oct. 2027) and potential implementation considerations for biopharmaceutical developers. The panel will include PDUFA and BsUFA negotiators from FDA, industry and BIO. We will also discuss renewal of the Biosimilars User Fee Act (BsUFA).