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Home » How to Use Real World Data and Evidence in Your FDA Submissions
How to Use Real World Data and Evidence in Your FDA Submissions
December 2, 2022
Over the past several years, the FDA has demonstrated an increasing willingness to consider real-world data (RWD) — data derived from sources other than traditional, tightly controlled clinical trials — in its regulatory decisionmaking. Sources of RWD are diverse but often include patient registries, medical records and information derived from wearable devices or apps.