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FDA Emergency IND – USA

Emergency IND Request (telephone/fax)21 CFR 312.3101 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

Emergency Investigational New Drug application for life-threatening situations requiring immediate treatment where there is no time to submit a formal IND. FDA may authorize treatment by telephone.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

FDA Emergency IND Guidance

Countries Using This Pathway (1)

US
United States
US
FDA Emergency IND – USA
Approval FormEmergency IND Request (telephone/fax)
Timeline1 days
Legal Status21 CFR 312.310
Source Ref.FDA Emergency IND Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified