Direct comparison
Expanded Access vs Compassionate Use
FDA "expanded access" and "compassionate use" are the same US program. See how it differs from the EU's separately-named EMA compassionate use pathway.
Side-by-side comparison
| Dimension | FDA Expanded Access (US) | EMA Compassionate Use (EU) |
|---|---|---|
| Formal name for the pathway | Expanded access ("compassionate use" is an informal synonym for this same program) | Compassionate use is itself the formal legal term |
| Legal basis | 21 CFR Part 312, Subpart I | Article 83, Regulation (EC) No 726/2004 |
| Who authorizes access | FDA, directly and centrally, for the whole US | Each EU Member State's national competent authority; the EMA/CHMP may issue a non-binding scientific opinion but does not itself authorize access |
| Geographic consistency | Single federal program, consistent across all US states | Fragmented by design — a programme for a given medicine may exist in some Member States and not others |
| Categories/structure | Three defined categories: individual patient, intermediate-size population, treatment IND/protocol | Typically structured as group-of-patients programmes at national level; no equivalent three-tier federal structure |
| Typical initiating party | Treating physician, often via FDA Form 3926 for individual-patient requests | Manufacturer or Member State health authority sets up the national programme; a CHMP opinion may be requested by a Member State |
| Related but distinct pathway | Right to Try Act (2018) — a separate route bypassing FDA authorization for that specific request | No direct equivalent covered here |
Common questions
FAQ
Is compassionate use the same as expanded access?+
In the United States, yes — they are the same FDA program under 21 CFR Part 312, Subpart I; "expanded access" is FDA's current formal name. In the European Union, "compassionate use" is a separate, formally-named pathway under Article 83 of Regulation (EC) No 726/2004, distinct from FDA's expanded access.
Does the EU have an equivalent to FDA's expanded access program?+
Yes, in purpose — the EU's compassionate use framework serves a similar function, but it is implemented by individual EU Member States rather than centrally. The EMA's CHMP can issue a scientific opinion on conditions of use, but the authorization itself remains a national decision.
Which pathway should a sponsor or physician use?+
It depends on jurisdiction: US access runs through FDA's expanded access program, while EU access runs through the relevant Member State's compassionate use programme. This page is a general orientation, not regulatory or legal advice for a specific product or patient.
Going deeper
