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PDUFA VIII. Demystified.

October 23, 2026
Grand Ballroom
Type: Plenary Session
The clock is ticking. PDUFA VIII is due to be enacted by Congress no later than September 30, 2027. What is the Prescription Drug User Fee Act (PDUFA) and why does it matter to patient advocates? This session will dive deep into this topic and the opportunities for patient advocates to be part of the process.
Moderator
Steve Berman
Vice President, Science and Regulatory Affairs Strategy
Biotechnology Innovation Organization (BIO)
Speakers
Jeff Allen, PhD
President and CEO
Friends of Cancer Research
Adora Ndu, PharmD, JD
Chief Regulatory Officer, and Executive Vice President of Portfolio Strategy and Management
BridgeBio Pharma, Inc.