What We Can Expect from PDUFA VIII
June 24, 2026
29AB
Type: Breakout Session
Focus Area:
Science and Regulatory Innovation
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 negotiators from industry and BIO.
Moderator
Speakers
Senior Vice President, Science & Regulatory Affairs
Biotechnology Innovation Organization (BIO)
Vice President, Science and Regulatory Affairs Strategy
Biotechnology Innovation Organization (BIO)
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