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FDA Drugs (New Approvals & NDA)
Original article

Expedited Investigational New Drug Pilot Program - Application Instructions

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Summary

FDA announces expedited investigational new drug pilot program application instructions with two-section requirements for sponsor information and research institution qualifications.

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FDAINDExpedited ProgramApplication InstructionsRegulatory

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Published by FDA Drugs (New Approvals & NDA) on October 5, 2026 7:19 PM

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