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Expanded Access: How to Submit a Request (Forms)

 

How to Submit a Request (Forms)

On average, FDA determines that 99% of all expanded access requests may proceed.

Drugs and Biologics

Important Information—When accessing Form FDA 3926 “Individual Patient Expanded Access Investigational New Drug Application (IND)” you may need to open the page in Internet Explorer or right click and save the document as a PDF to your desktop before opening it up.

Summary of Expanded Access Request Types (Drugs or Biologics)

Request TypeWho May Request Expanded Access
 Industry*Physician
1. Individual Patient IND
2. Emergency Use Individual Patient IND
3. Intermediate-Size Population IND
4. Treatment IND✔*
5. Individual Patient Protocol 
6. Emergency Use Individual Patient Protocol 
7. Intermediate-Size Population Protocol 
8. Treatment Protocol 

*Not typical given the criteria for Expanded Access Treatment INDs and Protocols

Refer to the expanded access categories and Title 21 of the Code of Federal Regulations (21 CFR) for more detailed information about expanded access request types.

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Licensed Physician Submitted Expanded Access Requests (as a protocol under a new IND)

Request Type
 
Forms and Resources
1. Non-Emergency Individual Patient IND (submitted prospectively)30-day waiting period to begin treatment, unless notified by FDA earlier.
Forms:
Process Step by Step:
Non-Emergency Individual Patient IND
2. Emergency Use Individual Patient IND (submitted retrospectively)Forms:

First, contact FDA for authorization. Treatment may begin immediately upon FDA authorization.


Process Step by Step:
Emergency Individual Patient IND
3. Intermediate-Size Population IND (submitted prospectively)Forms:
Process Step by Step:
Intermediate-size Population IND

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Non-Emergency Individual Patient or Intermediate-Size Population IND Expanded Access Submissions by a Licensed Physician [21 CFR 312.310 and 21 CFR 312.315]

ActionDescriptions and Further Information
1.Request a Letter of Authorization (LOA)
  • Request a Letter of Authorization (LOA) from the medical product developer.
  • The LOA is typically from the regulatory affairs official of the industry (company). FDA may be able to help identify the contact.
  • If a LOA is not available, submit sufficient information with the FDA Form 3926 (or 1571) for FDA to assure the product’s quality.
  • Letter of Authorization template
2.(A) INDIVIDUAL PATIENT IND: Submit Form FDA 3926*
(B) INTERMEDIATE-SIZE POPULATION IND: Submit Forms FDA 1571 and 1572

(A) INDIVIDUAL PATIENT IND:

(B) INTERMEDIATE-SIZE POPULATION IND:

Guidance Documents:

Other Resources:

3.Obtain IRB approval
  • Obtain IRB approval per 21 CFR Part 56.
  • A physician using Form FDA 3926 may choose to request authorization to obtain concurrence by the IRB chairperson or by a designated IRB member before the treatment use begins, in lieu of obtaining IRB review and approval at a convened IRB meeting at which a majority of the members are present.
  • A physician using Form FDA 1571 may include a separate waiver request with the application.
  • Database for Registered IRB's
4.Obtain Informed Consent
  • Obtain Informed Consent from patient or their legally authorized representative per 21 CFR Part 50.
  • Use a written consent form approved by the IRB.
5.Begin Treatment 30 days after application is received by FDA (or earlier if notified by FDA)
Note: Once the Intermediate-size Population IND is in effect, new patients can be enrolled and start treatment immediately.
  • For both individual patient and intermediate-size population INDs, the investigational drug or biologic may be shipped and treatment of the patient may begin 30 days after the application is received by FDA or earlier if notified by the FDA that treatment may proceed.
  • Note: The treating physician may need to provide the IND application number to the industry prior to the company shipping the investigational drug or biologic. This number will be provided upon FDA authorization of the expanded access request.
6.File Follow-up Report(s)

(A) INDIVIDUAL PATIENT IND:

(B) INTERMEDIATE-SIZE POPULATION IND:

*Physicians will still be able to use FDA Forms 1571 “Investigational New Drug Application (IND)” and Form 1572 “Statement of Investigator” for single patient expanded access submissions; however, Form 3926 is developed specifically for these requests and is easier to complete.

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Emergency Individual Patient IND Expanded Access Submissions by a Licensed Physician [21 CFR 312.310]

ActionDescriptions and Further Information
1.Request Letter of Authorization (LOA)
  • Request a Letter of Authorization (LOA) from the medical product developer.
     
  • The LOA is typically from the regulatory affairs official of the industry (company). FDA may be able to help identify the contact.
  • If a LOA is not available, submit sufficient information with the FDA Form 3926 (or 1571) for FDA to assure the product’s quality.
  • Letter of Authorization template.
2.Request FDA Emergency Use Authorization
3.Obtain Informed Consent
  • Obtain Informed Consent from patient or their legally authorized representative per 21 CFR Part 50.
  • Use a written consent form approved by the IRB.
  • Note: Informed Consent may be obtained prior to requesting FDA emergency use authorization.
4.If authorized by FDA, begin treatment
  • Authorization of the emergency use may be given by an FDA official by telephone (or other means of rapid communication).
  • The investigational drug or biologic may be shipped and treatment of the patient may begin immediately upon FDA emergency use authorization.
5.Notify IRB*
6.Submit Form FDA 3926** within 15 business days of FDA emergency use authorizationGuidance Documents: Other Resources:
7.File Follow-up Report(s)

*In an emergency, where there is not sufficient time to secure IRB review prior to beginning treatment, the emergency use of the investigational drug must be reported to the IRB within 5 working days, as required under 21 CFR 56.104(c).

**Physicians will still be able to use FDA Forms 1571 “Investigational New Drug Application (IND)” and Form 1572 “Statement of Investigator” for single patient expanded access submissions; however, Form 3926 is developed specifically for these requests and is easier to complete.

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Submit Individual Patient Expanded Access Applications by mail:

Investigational Drugs:

Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
ATTN: [appropriate Review Division]
“EXPANDED ACCESS SUBMISSION”
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266

Investigational Biologics:

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
Bldg. 71, Rm. G112
Silver Spring, MD 20993-0002

For other submission options, contact FDA.

Physicians will still be able to use FDA Forms 1571 “Investigational New Drug Application (IND)” and Form 1572 “Statement of Investigator” for single patient expanded access submissions; however, Form 3926 is developed specifically for these requests and is easier to complete.

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Industry Submitted Expanded Access Requests

Request TypeForms and Resources
  1. Individual Patient IND*
  2. Individual Patient Protocol**
  3. Intermediate-Size Population IND*
  4. Intermediate-Size Population Protocol**
  5. Treatment IND*
  6. Treatment Protocol**

(submitted prospectively)

Forms:
  1. Form FDA 1571 and Form FDA 1572
  2. Form FDA 1571 Instructions
  3. Form FDA 1572 Instructions
  4. Quick Guide to Forms 1571 and 1572
  5. Submit by the Electronic Submissions Gateway*
  1. Emergency Use Individual Patient IND
  2. Emergency Use Individual Patient Protocol

(submitted retrospectively)

First, contact FDA for authorization. Treatment may begin immediately upon FDA authorization.
Forms:

*IND requests: Submitted as a protocol to a new IND that references the IND holder’s existing IND. Treatment may begin 30 days after FDA receipt of the expanded access request, unless notified by FDA earlier. After the initial 30-day waiting period, for intermediate-size population INDs, once in effect, new patients can be enrolled and start treatment immediately.

**Protocol requests: Submitted as a new protocol under the IND holder’s existing IND. Treatment may begin as long as protocol is received by FDA and has IRB approval with the exception of Treatment Protocols submitted to an existing IND, which are subject to the same 30-day period as INDs.

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Non-Emergency IND or Protocol Expanded Access Submissions by Industry [21 CFR 312.310, 21 CFR 312.315 and 21 CFR 312.320]

ActionDescriptions and Further Information
1.Licensed Physician Contacts Industry
  • Licensed physician contacts industry about participation in the expanded access program.
2.Industry Submits Forms FDA 1571 and 1572Guidance Documents: Other Resources:
3.Obtain IRB approval
4.Licensed Physician Obtains Informed Consent
  • Obtain Informed Consent from patient or their legally authorized representative per 21 CFR Part 50.
  • Use a written consent form approved by the IRB.
5.Licensed Physician Begins Treatment
  • For Non-Emergency INDs and Treatment Protocols, the investigational drug or biologic may be shipped and treatment of the patient may begin 30 days after the application is received by FDA or earlier if notified by the FDA that treatment may proceed.
  • Non-Emergency Protocols (excluding Treatment Protocols), the investigational drug or biologic may be shipped and treatment of the patient may begin immediately as long as protocol is received by FDA and has IRB approval.
6.Industry Files Follow-up Report(s)

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Follow-up Expanded Access Reports

Submit follow-up reports using the same form as the original expanded access request, either Form FDA 3926 or Form FDA 1571

ActionTimeframeDescriptions and Further Information
Safety ReportsAs soon as possible but in no case later than 15 calendar days

Report unexpected fatal or life-threatening suspected adverse reactions to FDA as soon as possible but in no case later than 7 calendar days after the sponsor’s initial receipt of the information.

Report serious and unexpected suspected adverse reactions to FDA as soon as possible but in no case later than 15 calendar days after determining that the information qualifies for reporting.

Review the Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies.

See 21 CFR 312.32 for further information on mandatory safety reporting, as this table only summarizes some of the safety reporting requirements that are required.

AmendmentsAny time

Submit protocol and information amendments to FDA for any changes to the initial Expanded Access IND submission per 21 CFR Part 312 (312.30 and 312.31).

SummaryFollowing completion of treatment

For individual patients, when treatment is complete, submit a summary of expanded access use per 21 CFR 312.310(c)(2).

Annual ReportWithin 60 days of the anniversary date

For Expanded Access INDs, submit an annual report within 60 days of the anniversary date that the IND went into effect per 21 CFR 312.33.

The Annual Report is not required if treatment was completed and FDA was notified before one year passed.

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Medical Devices

There may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to help a patient suffering from a serious disease or condition for which there no other alternative therapy exists.

Expanded access requests for medical devices do not require use of an official FDA form.

Learn more about medical device expanded access requirements and how to submit a request.

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Additional Resources

Page Last Updated: 11/08/2018
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