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FDA (CDER)
GUIDANCE FINAL
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products
Published: 7/1/2026Detected: 7/1/2026

Summary preview

Submits next-generation sequencing (NGS) data to the FDA’s Division of Antiviral Products using an expected data submission structure and review-ready formats to support consistent scientific evaluation.

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infectious_disease
manufacturing
quality
clinical
safety
labeling
#next-generation sequencing
#NGS data submission
#antiviral products
#bioinformatics
#variant analysis

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