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How to Complete Form FDA 1571 and Form FDA 1572

On this page, you will find information about completing Form FDA 1571 and Form FDA 1572.

Form FDA 1571, Investigational New Drug Application (IND), is currently the approved form for submitting requests for an individual patient expanded access to investigational drugs (including biologics).

Form FDA 1572, Statement of Investigator, provides the identity and qualifications of the investigator conducting the clinical investigation.

The IND should include the following information: 

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.

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

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.

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.

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.

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.

Visit the Expanded Access (Compassionate Use) Main Page

Page Last Updated: 02/03/2015
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