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Session 5: Use of RWE in Label Expansion
Session Chair(s)
Paul M. Coplan, DrSc, MBA, MSc, FISPE
VP, Medical Device Epidemiology & Real-World Data Analytics
Johnson & Johnson, United States
Marni Hall, PhD, MPH
Vice President and General Manager, Global Regulatory Science and Strategy
IQVIA, United States
21st Century Cures Act and the current user fee commitments direct and give FDA the authority to develop a framework for use of real world evidence for indication expansion. This section will discuss the current landscape, examples of when RWE protocols have been accepted by FDA for label expansion, and strategies for more broad application, including the criteria for routine use.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe three criteria in which RWE has been used for label expansion
- Explain why it will be necessary to employ different assessments for different therapeutic areas
- Propose one or more pilot projects to advance a framework for use of RWE for label expansion
Speaker(s)
Use of Real World Evidence to Expand Labels: Expectations, Opportunities, and Challenges
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER
Use of RWE in Label Expansion
Nancy A Dreyer, PhD, MPH, FISPE
Dreyer Strategies LLC, United States
Founder
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