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 Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA

News • 12/05/25

Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA

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Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned

 

On September 23, 2025, experts convened to discuss lessons learned from case studies in which RWE was used for regulatory decision-making for medical products. Speakers highlighted FDA’s efforts with RWD/E to date and approaches to generate RWE to meet regulatory requirements.

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