FDA Biologics (BLA & Biosimilars)Original article
Expedited Investigational New Drug Pilot Program - Application Instructions
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Summary
The FDA has issued application instructions for its Expedited Investigational New Drug Pilot Program, detailing the two-section format required for sponsor submissions and research institution qualifications.
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FDAINDRegulatory GuidanceApplication Process
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Published by FDA Biologics (BLA & Biosimilars) on October 5, 2026 7:19 PM