Physician Request for Single Patient IND for Compassionate or Emergency
Use
To request an Investigational New Drug (IND) application to use an unapproved
drug or other product for a single patient, the first step is to have
your physician obtain permission from the manufacturer in writing, or
in an emergency, by telephone. After the manufacturer agrees to provide
the product, the recommended procedure is to submit the following information
to the appropriate review division at the FDA. The request may be made
by fax with a letter to follow.
Clearly Label Your Request by writing "Request
for a single patient IND for Compassionate or Emergency Use" on
the top of all correspondence.
A Brief Clinical History of the patient, including
the diagnosis, the disease status, prior therapy received, the response
to prior therapy, and the rationale for requesting the proposed treatment.
Your Proposed Treatment Plan including the dose, route,
planned duration, monitoring procedures, and any protocol modifications
for toxicity (for example, dose reduction or treatment delay). Reference
a published protocol or journal article, if appropriate.
Include a Drug Supply Reference Statement, which would
name the supplier or manufacturer, and a Letter of Authorization from
the manufacturer. The treating physician must contact the supplier or
manufacturer for such a statement. This letter will contain the manufacturer's
IND number.
Sign an Informed Consent Statement that states that
informed consent and approval of an appropriate Institutional Review
Board (IRB) will be obtained prior to initiating treatment. There are
some IRBs that have specific procedures for approving emergency requests.
The IRB of the hospital where the physician works would typically handle
this.
Include an Investigator Qualification Statement that
specifies the training, experience, and licensure of the treating physician.
The first two pages of a physician’s Curriculum Vitae typically
contain this information and are usually sufficient.
Complete FDA Form 1571 with the treating physician
listed as the sponsor. This form can be downloaded
from the FDA's website.
If the request is approved, an IND number will be issued by the FDA
and the treating physician will be contacted by phone 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 who will then, in turn, arrange to make the
drug available to the patient.
For further information, your physician should contact the Oncology
Drug Products FDA Review Division by phone at (301) 594-2473 or fax at
(301) 594-0499.
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