Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Expanded access (compassionate use)

United States · Food and Drug Administration · New drugs

Early or compassionate accessHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

2 requirements

Application fee

What is the Expanded access (compassionate use) in United States?

An unapproved investigational drug can be used to treat patients outside clinical trials when they have a serious or immediately life-threatening condition and no comparable or satisfactory alternative. Requests can cover one patient, a group, or a wider treatment use. In an emergency, use can start before a written request. Patients who cannot enter a clinical trial and have no satisfactory alternative.

What are the steps of the Expanded access (compassionate use)?

1. Physician or sponsor sends a request; 2. Emergency start (if needed); 3. Agency decision.

Outcome: Permission to use the investigational product for treatment.

Legal basis: 21 CFR Part 312 Subpart I

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Physician or sponsor sends a request
2. Emergency start (if needed)only in some casesIn an emergency, the agency can let use begin without a written submission.
3. Agency decision

Requirements

What the applicant must provide or meet

Eligibility

Serious condition and no alternativeA serious or immediately life-threatening disease or condition, with no comparable or satisfactory alternative therapy.

Clinical data

Benefit justifies riskThe potential benefit to the patient justifies the potential risks.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in United States: New drug application (full, new active ingredient), New drug application relying on other data (505(b)(2)), Abbreviated new drug application (generic), Biosimilar application (351(k)), Biologics license application (351(a)), Over-the-counter monograph order, Prescription to nonprescription switch, Breakthrough therapy designation, Fast track designation, Accelerated approval, Priority review, Regenerative medicine advanced therapy designation, Orphan drug designation, National priority voucher (pilot). See all routes on the or explore them in the .

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.