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Monday, June 19 • 11:00am - 12:15pm
#114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Kim M. Quaintance-Lunn

Speaker

Panelist
Theresa M. Mullin, PhD

FDA Perspective
Patrick Frey

Industry Perspective
Sandra A. Milligan, JD, MD

Panelist
Lucy Vereshchagina, PhD


Moderators
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, Regulatory Policy, North American Regulatory Affairs, Bayer
Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, North American Regulatory Affairs, at Bayer. Kim joined Bayer in February 2014 to establish and lead the US regulatory policy function for the organization. She works with colleagues to analyze regulatory policy... Read More →

Speakers
avatar for Patrick Frey

Patrick Frey

Chief of Staff, Office of New Drugs, CDER, FDA
Patrick Frey is the Chief of Staff in CDER's Office of New Drugs. He has played leadership roles in the reauthorization of PDUFA V and VI as well as BSUFA II. He was also the CDER lead in developing and implementing CDER's structured framework for benefit-risk assessment. Patrick... Read More →
avatar for Sandra Milligan

Sandra Milligan

Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories
Sandra Milligan serves as senior vice president and head of Global Regulatory Affairs and Clinical Safety at Merck. She is a graduate of George Washington University School of Medicine and Georgetown University Law Center. Sandy served on DIA’s board from 2011 to 2017, served on... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002... Read More →
LV

Lucy Vereshchagina

Deputy Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Dr. Vereshchagina is a Deputy Vice President at the Pharmaceutical Research and Manufacturers of America or PhRMA. She leads the Regulatory Advocacy team with the focus on the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), as well as other regulatory... Read More →

Monday June 19, 2017 11:00am - 12:15pm
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Forum