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Regenerative
Clinic Guide
Regulation

Expanded access

Also known as: compassionate use

A pathway for treatment use of an investigational product outside a clinical trial when the applicable eligibility and oversight requirements are met.

Source-checked educational compilation · Not independently clinically reviewed

What this means in a clinic conversation

FDA describes this for serious or immediately life-threatening conditions without a comparable satisfactory alternative. It is a specific access process, not general permission to market an investigational treatment.

A question to bring

Which expanded-access pathway is proposed, and who is arranging the required permissions?

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Related and commonly confused terms

Use the term in context

Sources and editorial context

This definition was compiled from the sources below and has not received independent clinical review. It supports understanding and consultation preparation.

  1. IND Applications for Clinical Treatment (Expanded Access): Overview · U.S. Food and Drug AdministrationReference checked 2026-10-02
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