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Session 8A: Business Track - FDASIA Update
Session Chair(s)
Kim Quaintance-Lunn
Vice President, Regulatory Affairs Americas
Bayer AG, United States
This session will continue the update on the Food and Drug Administration Safety and Innovation Act (FDASIA). The focus will be on expedited approval pathways and breakthrough therapy designation, the NME review program, and structured benefit-risk including Patient Focused Drug Development. Panelists will discuss what was in FDASIA/PDUFA V, implementation, industry experience, and looking ahead.
Speaker(s)
Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs
Kim Quaintance-Lunn
Bayer AG, United States
Vice President, Regulatory Affairs Americas
Expedited Development Programs
Khyati Roberts, RPh
Retired, United States
Retired
Structured Benefit/Risk & Patient Focused Drug Development
Jayne Ware, MPH, MSc
Merck Sharp & Dohme LLC , United States
Senior Director, Global Regulatory Policy
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