Name: FDA Accelerated Approval Program: Putting Withdrawals in Context
Start: 2025-06-16T15:45:00-0400
End: 2025-06-16T16:45:00-0400

Monday June 16, 2025 3:45pm - 4:45pm EDT

TBD

Component Type: Session
Level: Intermediate

FDA's Accelerated Approval Program has been criticized for delays in withdrawing approved therapies when clinical benefit is not confirmed. This is a small percentage of drugs, however, and the reasons need to be understood in overall context.

Learning Objectives

Examine the current fragmentation in RWD/RWE data quality standards and its impact on research and regulatory decisions; Identify the key stakeholders and their varying data quality criteria within the pharmaceutical landscape; Explore potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.

Chair

Bridget Doherty, MPH, MS

Speakers

Bridget Doherty

Director, Market Access Scientific and External Strategy, Janssen Scientific Affairs, United States

Bridget Doherty, MPH, is director of Market Access Scientific and External Strategy at Janssen Scientific Affairs where she develops evidence and insights around U.S. healthcare policies and their impact on patient access and outcomes. She has held leadership roles within scientific... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Format Session
Level Intermediate
Level Intermediate
format csv
Tags Session

DIA 2025 Global Annual Meeting

Bridget Doherty

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