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FDA - Investigational New Drug Programme IND (Jan 2007)

When a physician needs an Investigational New Drug (IND) application request to use an unlicensed drug or other product for a single patient, the first step is to obtain permission from the manufacturer. Without the consent of the manufacturer, the unlicensed product cannot be made available for the patient.

After the manufacturer has agreed to provide the product, the recommended procedure is to submit the following information to the appropriate review division. The request may be made by facsimile with a letter to follow. Following is a document from the FDA’s web site that explains what they refer to as the “Single Patient IND for Compassionate or Emergency Use” process.

U.S. Food and Drug Administration / Centre for Drug Evaluation and Research. Investigational New Drug (IND) Program, USA. It was set up to address cancer treatments at the time but the process is the same for any life threatening disease.

Physician Request for a Single Patient IND for Compassionate or Emergency Use Guidance                                                                                        

1. Request for a single patient IND for Compassionate or Emergency Use should be stated at the top of the correspondence.
2. Brief Clinical History of the patient including the diagnosis, the disease status, prior therapy, response to prior therapy and the rationale for requesting the proposed treatment.
3. Proposed Treatment Plan including the dose, route, planned duration, monitoring procedures and modifications (e.g. dose reduction or treatment delay) for toxicity.
4. Reference a published protocol or journal article if appropriate.
5. Drug Supply Reference Statement which would name the supplier or manufacturer and a statement that a Letter of Authorization to cross reference an appropriate IND of the supplier or Drug Master File (DMF) of the manufacturer is included.
6. The treating physician must contact the supplier or manufacturer for such a statement.
7. Informed Consent Statement that states that the informed consent and approval of an appropriate Institutional Review Board (IRB) will be obtained prior to obtaining treatment. There are some IRB’s that have specific procedures for approving emergency requests.
8. 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.
9. FDA Form 1571 completed with the treating physician listed as the sponsor. Form 1571 and other forms can be downloaded from the Internet. fda.gov
10. Contact telephone number and facsimile number. If the request is approved, an IND number will be issued by the FDA and the treating physician will be contacted by telephone or fax with a letter to follow. The IND is considered active upon issuance of the number. The IND sponsor (treating physician) will then contact the drug supplier and provide the IND number. The supplier may then ship the drug directly to the treating physician.

Additional information is available on their website - fda.gov - Including forms that need to be filled out by the doctor.

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