• Form FDA 3926 (or Forms FDA 1571 and 1572)* by mail
• Form FDA 3926 Instructions

• 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.

• 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

• 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

(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)

• 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

• Obtain Informed Consent from patient or their legally authorized representative per 21 CFR Part 50.
• Use a written consent form approved by the IRB.

• 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.

(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.

• 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.

• Contact the appropriate FDA review division or organization by telephone (or other rapid means of communication).

• 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.

• 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.

• Within 5 business days of treatment initiation, notify the IRB.
• Database for Registered IRB's.

• 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.

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

• Expanded Access Categories for Drugs (Including Biologics)

• Submit Form FDA 3926 to FDA via mail. For other submission options, contact FDA.

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)

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*

7. Emergency Use Individual Patient IND
8. Emergency Use Individual Patient Protocol

(submitted retrospectively)

• 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*

• Licensed physician contacts industry about participation in the expanded access program.

• 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

• Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers

• Expanded Access Categories for Drugs (Including Biologics)

• Obtain IRB approval per 21 CFR Part 56.
• Database for Registered IRB's

• Obtain Informed Consent from patient or their legally authorized representative per 21 CFR Part 50.
• Use a written consent form approved by the IRB.

• 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.

• Submit Form FDA 1571 to FDA via the Electronic Submissions Gateway*

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.

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).

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

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.