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FDA Expanded Access (Compassionate Use) – USA

FDA Form 3926 (Individual Patient IND)21 CFR Part 312 Subpart I30 days

Contents

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

Description & Eligibility

FDA program allowing patients with serious or immediately life-threatening conditions to access investigational drugs, biologics, or medical devices outside of clinical trials.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

FDA Expanded Access Guidance

Countries Using This Pathway (1)

US
United States
US
FDA Expanded Access (Compassionate Use) – USA
Approval FormFDA Form 3926 (Individual Patient IND)
Timeline30 days
Legal Status21 CFR Part 312 Subpart I
Source Ref.FDA Expanded Access Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified