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Field Label | Description/Instructions | ||||||
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Studies a U.S. FDA-regulated Drug Product |
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Studies a U.S. FDA-regulated Device Product |
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Unapproved/Uncleared Device* |
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Pediatric Post-market Surveillance |
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Product Exported from the U.S. |
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FDA Regulated Intervention Indicator* |
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Section 801 Indicator* |
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Data Monitoring Committee Appointed Indicator |
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