FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance
FDA Law Blog
SEPTEMBER 10, 2023
Even though an IND is not required, this guidance is intended to provide recommendations for sponsors to follow for using RWE from such studies for regulatory decision-making. The COVID-19 vaccines were initially authorized under EUAs, but their approvals do not appear to have been based on RWE.
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