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Guidance Documents/Guidance-Document/Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 22, 2023

February 3, 2025

Center for Drug Evaluation and Research

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