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FDA Drugs (New Approvals & NDA)
Original article

Phase 1 IND Procedures and Policies

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Summary

FDA guidance document on Phase 1 IND procedures and policies. This is a routine informational resource from the FDA regarding investigational new drug submission processes.

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regulatoryguidancePhase 1IND

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Published by FDA Drugs (New Approvals & NDA) on September 3, 2026 1:41 PM

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