A majority of the Expedited IND Pilot will take place during the “Pre-IND” phase – the period of nonclinical development before the sponsor submits their official 30-day IND application.
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The application will consist of two sections: 1) Sponsor and Investigative New Drug Information, and 2) Prospective Research Institution Qualifications.
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The FDA Expedited IND Pilot Program is an initiative under HHS Operation TrialBlazer designed to evaluate new approaches for accelerating first-in-human (FIH) clinical trials in the United States while maintaining FDA's rigorous standards for participant safety and scientific oversight.
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History of all updates to the application software in reverse chronological order by version number
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Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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Treatment of neurologic manifestations of mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A) in pediatric patients with preserved neurodevelopmental function.
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FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
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Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER
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Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).
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Contains names, addresses, and other information gathered from inspections of clinical investigators (E-K) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).
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Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).
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Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER
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