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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
          Expanded Access (Compassionate Use) Submission Data
          FDA's Expanded Access Contact Information Home
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          Expanded Access
          How to Complete Form FDA 1571 and Form FDA 1572Expanded Access How to Complete Form FDA 1571 and Form FDA 1572
  
  	
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    PrintOn this page, you will find information about completing Form FDA 1571 and Form FDA 1572.

Form FDA 3926 can be used by physicians when submitting requests for individual patient expanded access to investigational drugs, including in emergencies. This form is designed specifically for single patient IND requests. It can also be used for certain submissions to FDA after the initial application is filed. For more information, including instructions, please visit the guidance Individual Patient Expanded Access Applications: Form FDA 3926.

Physicians will still be able to use Investigational New Drug Application Form 1571 and 1572 for single patient expanded access submissions; however, Form 3926 is developed specifically for these requests and should be easier to complete. Form FDA 1571 and 1572 are still required for other expanded access submissions (e.g., intermediate access or treatment INDs) and for IND submissions by commercial sponsors or drug manufacturers.

The IND should include the following information:

1. Statement that this is a request for an individual patient IND for treatment use

You will need to specify whether it is an emergency IND or individual patient IND. This statement should be at the top of the correspondence and on the mailing cover.

2. Provide a brief clinical history of the patient including:

When submitting your request you will need to provide the FDA with the following information about your patient:

the diagnosis
	the disease status
	prior therapy
	response to prior therapy
	the rationale for requesting the proposed treatment, including a list of available therapeutic options that would ordinarily be tried before the investigational drug or an explanation of why use of the investigational drug is preferable to use of available therapeutic options

3. Indicate the proposed treatment plan including:

When submitting your request you will need to provide the FDA with the following information about your patient:

the dose
	route
	planned duration
	monitoring procedures
	modifications (e.g. dose reduction or treatment delay) for toxicity.Reference a published protocol or journal article if appropriate.

4. Include the chemistry, manufacturing, and controls information and pharmacology and toxicology information

In your application you will need to include a description of the manufacturing facility.

The requirement for this information may be met by providing a Letter of Authorization (LOA) to refer to this information if it has been previously submitted to FDA (for example, to an existing IND or NDA).

The treating physician should contact the sponsor of the previously submitted information for such authorization and letter.

The letter of authorization should include relevant identifying information, such as the sponsor’s relevant application (e.g., IND) number.

5. Provide a copy of the informed consent statement

When you submit your request you will need to provide a statement that states that informed consent and approval of the use by an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment.

In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment.

6. Submit the Physician Investigator Qualification Statement

You will need to provide the FDA with the a statement that specifies the training, experience, and licensure of the treating physician. This can usually be found on the the first two pages of a Curriculum Vitae typically contain this information and are usually sufficient.

7. Forms: FDA 1571 and FDA 1572

Instructions For Filling Out Form FDA 1571
	Form FDA 1571
	Form FDA 1572

Visit the Expanded Access (Compassionate Use) Main Page

                                                                                  Content current as of:
      11/13/2019Expanded 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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