Expanded Access | How to Submit a Request (Forms)
On average, FDA determines that 99% of all expanded access requests may proceed.
Physicians can now request individual patient expanded access for drugs and biologics in non-emergency settings using Expanded Access eRequest.
On this page, you will find information about:
Forms and Processes for Drug or Biologic Expanded Access Requests:
- Summary of Expanded Access Request Types
- Drug Info Rounds Expanded Access Video Series
- Licensed Physician Submitted Expanded Access Requests
- Industry Submitted Expanded Access Requests
- How to Submit a Follow-up Expanded Access Reports
Processes for Medical Device Expanded Access Requests:
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 Type | Who 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.
- 21 CFR 312.310 Individual patients, including emergency use
- 21 CFR 312.315 Intermediate-size patient populations
- 21 CFR 312.320 Treatment IND or treatment protocol
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 |
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]
Action | Descriptions and Further Information | |
---|---|---|
1. | Request a Letter of Authorization (LOA) |
|
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 |
|
4. | Obtain Informed Consent |
|
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. |
|
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.
Emergency Individual Patient IND Expanded Access Submissions by a Licensed Physician [21 CFR 312.310]
Action | Descriptions and Further Information | |
---|---|---|
1. | Request Letter of Authorization (LOA) |
|
2. | Request FDA Emergency Use Authorization |
|
3. | Obtain Informed Consent |
|
4. | If authorized by FDA, begin treatment |
|
5. | Notify IRB* |
|
6. | Submit Form FDA 3926** within 15 business days of FDA emergency use authorization |
|
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.
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.
Industry Submitted Expanded Access Requests
Request Type | Forms and Resources |
---|---|
(submitted prospectively) |
Forms:
|
(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.
Non-Emergency IND or Protocol Expanded Access Submissions by Industry [21 CFR 312.310, 21 CFR 312.315 and 21 CFR 312.320]
Action | Descriptions and Further Information | |
---|---|---|
1. | Licensed Physician Contacts Industry |
|
2. | Industry Submits Forms FDA 1571 and 1572 |
|
3. | Obtain IRB approval |
|
4. | Licensed Physician Obtains Informed Consent |
|
5. | Licensed Physician Begins Treatment |
|
6. | Industry Files Follow-up Report(s) |
|
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
Action | Timeframe | Descriptions and Further Information |
---|---|---|
Safety Reports | As 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. |
Amendments | Any 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). |
Summary | Following 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 Report | Within 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. |
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.
Additional Resources
Guidance Documents:
- Individual Patient Expanded Access Applications: Form FDA 3926
- Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers
- FDA Final Guidance: Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
- FDA Final Guidance: Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors
Other Resources:
- Expanded Access Categories for Drugs (Including Biologics)
- Expanded Access: Criteria for an Investigational Product to be Made Available For Widespread Use Under a Treatment Protocol or Treatment IND/ Treatment IDE
- Search for citations of Title 21 in the Code of Federal Regulations (21 CFR) online at the Electronic Code of Federal of Regulations