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
Postmarketing safety reporting obligations apply, but, if the sponsor is using only a subset of a larger dataset to conduct its analysis, FDA does not expect the sponsor to search the entire dataset regarding all uses of the product for adverse events that would meet reporting requirements.
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