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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI

Session Chair(s)

Kim  Quaintance-Lunn

Kim Quaintance-Lunn

Vice President, Head of Regulatory Science and Execution

Alexion, United States

Development and approval timelines for drugs and therapeutic biologic products affect us all. This will be the first reauthorization occurring in parallel with a new Congress and a new administration. This session will focus on how PDUFA has affected both the regulator and regulated industry and what we can expect in the sixth iteration of the agreement.

Learning Objective : Discuss a historical review of PDUFA from expediting approvals to expediting development; Identify what's new in PDUFA VI and the impact on sponsor and regulator.

Speaker(s)

Theresa  Mullin, PhD

Panelist

Theresa Mullin, PhD

FDA, United States

Associate Center Director - Strategic Initiatives, CDER

Patrick  Frey

FDA Perspective

Patrick Frey

Neurocrine Biosciences, United States

Senior Director, Regulatory Policy

Sandy  Milligan, JD, MD

Industry Perspective

Sandy Milligan, JD, MD

Innovex Strategies, United States

Board of Director Member, Gossamer Bio; Principal

Lucy  Vereshchagina, PhD

Panelist

Lucy Vereshchagina, PhD

PhRMA, United States

Vice President, Science and Regulatory Advocacy

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