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
SEPTEMBER 10, 2023
An interesting addition in the final guidance is that it explains that the topics discussed “apply to any type of RWD, including data on products used in clinical practice under an emergency use authorization (EUA).” For obvious reasons, EUAs have been more prominent in recent years than they had been previously.
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