Physician Request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use

When a physician would like to submit an Investigational New Drug application (IND) to obtain an unapproved drug for an individual patient, he or she should first ensure that the manufacturer of the unapproved drug is willing to provide the drug. If the manufacturer agrees to provide the drug, the physician should submit an IND to the appropriate review division.

In an emergency situation, the request to use the drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone.  In these situations, known as emergency INDs, shipment of and treatment with the drug may begin prior to FDA’s receipt of the written IND submission that is to follow the initial request.

In a non-emergency situation, a written request (IND) for individual patient use of an investigational drug must be received by the FDA before shipment of and treatment with the drug may begin.  These non-emergency requests are known as individual patient INDs.  The IND should include the following information:

1. Statement that this is a request for an individual patient IND for treatment use (specifying whether it is an emergency IND or individual patient IND) should be at the top of the correspondence and on the mailing cover.
    
2. Brief Clinical History of the patient including:
   • 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. Proposed Treatment Plan including:
   • 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. Chemistry, Manufacturing, and Controls Information and Pharmacology and Toxicology Information, including 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. Informed Consent 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. Investigator Qualification Statement that specifies the training, experience, and licensure of the treating physician. The first two pages of a Curriculum Vitae typically contain this information and are usually sufficient.
    
7. FDA Form 1571 completed with the treating physician listed as the sponsor. You can download Form 1571 and other forms from the FDA Web site. For forms and instructions please see: Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs).
    
8. Contact telephone number and facsimile number.

 

A number will be assigned to the application. The IND sponsor (treating physician) should provide this IND number to the drug supplier, so the supplier may ship the drug to the treating physician. The FDA will either allow the treatment use to proceed or not allow it to proceed (put the application on clinical hold).  The IND is considered active (treatment with the drug may proceed) 30 days after FDA receives the IND submission or upon earlier notification of the physician by FDA.  If the treatment use is not allowed to proceed (i.e., a clinical hold is placed on the application), FDA will notify the physician of this decision initially via a telephone call.  The call will be followed by a written letter that provides the reasons for FDA's denial of the request.

For further information, please contact the appropriate Review Division.

CDER Review Division	Telephone Number	FAX Number
Division of Anti-Viral Products	301-796-1500	301-796-9883
Division of Oncology Products 1	301-796-2330	301-796-9845
Division of Oncology Products 2	301-796-2320	301-796-9849
Division of Hematology Products	301-796-7550	301-976-9849
Division of Reproductive and Urologic Products	301-796-2130	301-796-9897
Division of Medical Imaging Products	301-796-2050	301-796-9848
Division of Gastroenterology and Inborn Errors Products	301-796-2120	301-796-9905
Division of Anesthesia, Analgesia, and Addiction Products	301-796-2280	301-796-9723
Division of Metabolism and Endocrinology Products	301-796-2290	301-796-9712
Division of Pulmonary, Allergy and Rheumatology Products	301-796-2300	301-796-9728
Division of Dermatology and Dental Products	301-796-2110	301-796-9895
Division of Anti-Infective Products	301-796-1400	301-796-9883
Division of Transplant and Ophtalmology Products	301-796-1600	301-796-9840
Division of Cardiovascular and Renal Products	301-796-2270	301-796-9840
Division of Neurology Products	301-796-2250	301-796-9839
Division of Psychiatry Products	301-796-2260	301-796-9838