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
Interventional studies are generally clinical investigations under the regulations and thus require an IND under 21 C.F.R. § 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).”
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