FDA Drugs (New Approvals & NDA)Original article
Expedited IND Rolling Submission Process and Program Structure
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Summary
FDA describes the structure of its Expedited IND Pilot, noting that most of the program occurs in the Pre-IND phase of nonclinical development before the sponsor submits the official 30-day IND application. The article does not mention any specific company, drug, or product.
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FDAINDExpedited IND PilotPre-INDregulatory process
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Published by FDA Drugs (New Approvals & NDA) on October 16, 2026 7:28 PM