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Guidance Documents/Guidance-Document/Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

May 20, 2026

May 20, 2026

Center for Drug Evaluation and Research

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