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                Expanded Access

Expanded Access

                        Expanded Access | Information for Patients
          Expanded Access | Information for Physicians
          Expanded Access | Information for Industry
          Expanded Access | How to Submit a Request (Forms)
          Expanded Access | Keywords, Definitions, and Resources
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          Expanded Access | How to Submit a Request (Forms)Expanded Access Expanded Access | How to Submit a Request (Forms)
  
  	
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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
	How to Submit a Non-Emergency Individual Patient IND
		Step-by-step instructions
		How to Submit an Emergency Use Individual Patient IND
		Step-by-step instructions
		How to Submit an Intermediate-Size Population IND
		Step-by-step instructions
	Industry Submitted Expanded Access Requests
	Non-Emergency IND or Protocol Expanded Access Submissions
		Emergency Expanded Access Requests
	How to Submit a Follow-up Expanded Access Reports**Processes for Medical Device Expanded Access Requests:**

Medical Devices

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 AccessIndustry*
			Physician1. 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 protocolBack to Top

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:**
			Form FDA 3926 (or Forms FDA 1571 and 1572)* by mail
				Form FDA 3926 Instructions**Process Step by Step:**Non-Emergency Individual Patient IND**2. Emergency Use Individual Patient IND (submitted retrospectively)**
			**Forms:**
			Form FDA 3926 (or Forms FDA 1571 and 1572)* by mail
				Form FDA 3926 Instructions**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:**
			Form FDA 1571 and Form FDA 1572 by mail in triplicate (the original and two photocopies are acceptable)
				Form FDA 1571 Instructions
				Form FDA 1572 Instructions
				Quick Guide to Forms 1571 and 1572**Process Step by Step:**Intermediate-size Population INDBack to Top

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 Information1.
			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 template2.
			(A) INDIVIDUAL PATIENT IND: Submit Form FDA 3926*
			(B) INTERMEDIATE-SIZE POPULATION IND: Submit Forms FDA 1571 and 1572
			**(A) INDIVIDUAL PATIENT IND:**

			Submit Form FDA 3926 (along with the LOA) to FDA via mail. For other submission options, contact FDA.
				Form FDA 3926 Instructions.
				Complete Form FDA 3926 and upload LOA using Expanded Access eRequest**(B) INTERMEDIATE-SIZE POPULATION IND:**

			Form FDA 1571 and Form FDA 1572
				Form FDA 1571 Instructions
				Form FDA 1572 Instructions
				Quick Guide to Forms 1571 and 1572**Guidance Documents:**

			Individual Patient Expanded Access Applications: Form FDA 3926
				Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers**Other Resources:**

			Expanded Access Categories for Drugs (Including Biologics)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's4.
			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.
				Example template for Informed Consent for Individual Patient IND5.
			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:**

			Submit Form FDA 3926 to FDA via mail. For other submission options, contact FDA.**(B) INTERMEDIATE-SIZE POPULATION IND:**

			Submit Form FDA 1571 to FDA via mail. 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.*

Back to Top

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

Action
			Descriptions and Further Information1.
			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
			Contact the appropriate FDA review division or organization by telephone (or other rapid means of communication).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.*
				Example template for Informed Consent for Individual Patient IND4.
			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*
			Within 5 business days of treatment initiation, notify the IRB.
				Database for Registered IRB's.6.
			Submit Form FDA 3926** within 15 business days of FDA emergency use authorization
			Within 15 business days of FDA emergency use authorization, submit Form FDA 3926 (along with the LOA) to FDA via mail. For other submission options, contact FDA.
				Instructions for filling out Form FDA 3926 are available online.
			Guidance Documents:

			Individual Patient Expanded Access Applications: Form FDA 3926
				Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers
			Other Resources:

			Expanded Access Categories for Drugs (Including Biologics)7.
			File Follow-up Report(s)
			Submit Form FDA 3926 to FDA via mail. For other submission options, contact FDA.**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.*

Back to Top

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.*

Back to Top

Industry Submitted Expanded Access Requests

Request Type
			Forms and ResourcesIndividual Patient IND*
				Individual Patient Protocol**
				Intermediate-Size Population IND*
				Intermediate-Size Population Protocol**
				Treatment IND*
				Treatment Protocol***(submitted prospectively)*
			**Forms:**
			Form FDA 1571 and Form FDA 1572
				Form FDA 1571 Instructions
				Form FDA 1572 Instructions
				Quick Guide to Forms 1571 and 1572
				Submit by the Electronic Submissions Gateway*Emergency Use Individual Patient IND
				Emergency Use Individual Patient Protocol*(submitted retrospectively)*
			**First, contact FDA for authorization. Treatment may begin immediately upon FDA authorization.****Forms:**
			Form FDA 1571 and Form FDA 1572 within 15 business days of FDA authorization
				Form FDA 1571 Instructions
				Form FDA 1572 Instructions
				Quick Guide to Forms 1571 and 1572
				Submit by the Electronic Submissions Gateway****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.

Back to Top

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 Information1.
			Licensed Physician Contacts Industry
			Licensed physician contacts industry about participation in the expanded access program.2.
			Industry Submits Forms FDA 1571 and 1572
			Submits Form FDA 1571 and Form FDA 1572
				Form FDA 1571 Instructions
					Form FDA 1572 Instructions
					Quick Guide to Forms 1571 and 1572
				IND requests: Submitted as a protocol to a new IND that references the IND holder’s existing IND
				Protocol requests: Submitted as a new protocol under the IND holder’s existing IND**Guidance Documents:**

			Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers**Other Resources:**

			Expanded Access Categories for Drugs (Including Biologics)3.
			Obtain IRB approval
			Obtain IRB approval per 21 CFR Part 56.
				Database for Registered IRB's4.
			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.
				Example template for Informed Consent for Individual Patient IND5.
			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)
			Submit Form FDA 1571 to FDA via the Electronic Submissions Gateway*Back to Top

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 InformationSafety 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.Back to Top

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.

Back to Top

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

                                                                                  Content current as of:
      11/29/2023Expanded Access

          
                        Information for Patients
          Information for Physicians
          Information for Industry
          How to Submit a Request (Forms)
          Keywords, Definitions, and Resources
          Submission Data
          Contact Information
 
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