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The Growing Role of the Patient Leading Into PDUFA VI: Negotiations and 2016
Session Chair(s)
James Valentine, JD, MHS
Director
Hyman, Phelps & McNamara, PC, United States
FDA’s Patient-Focused Drug Development (PFDD) initiative is three years old. Not only have the meetings generated a great deal of information on patients' perspectives, but they've also generated a lot of questions. How can this growing body of information be translated into a useful set of data for the agency? How has the agency started incorporating these patient perspectives into regulatory decision-making, and what's been the impact? What are the lessons learned that can inform future patient-focused efforts in PDUFA VI and beyond? Are there other models that may take shape as PFDD 2.0? How can stakeholders engage and collaborate with FDA as negotiations and stakeholder consultations move forward for PDUFA VI? These questions, and more, will be explored by FDA officials and other stakeholders involved in the PFDD initiative.
Learning Objective : Describe achievements of patient-centered drug development program thus far; Identify lessons learned; Anticipate next steps.
Speaker(s)
Looking Forward for PDUFA VI: Opportunities for Patient Engagement with FDA
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
The Patient Perspective: Assessment of the Current Program and Future Opportunities
Diane Edquist Dorman
dDConsulting LLC, United States
Patient Advocacy Expert
Perspective From Industry
Mary O'Donovan, MS
BioMarin Pharmaceutical Inc., United States
Executive Director
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