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  1. Expanded Access

Example of Wording for Letter Requesting Authorization to Use Alternative Institutional Review Board (IRB) Review Procedures

Intended for use with a non-emergency individual patient expanded access Investigational New Drug Application (IND) request, accompanied by a completed Form FDA 1571. 1, 2  

[INSTITUTION LETTERHEAD PROVIDING INSTITUTION NAME, ADDRESS, AND TELEPHONE NUMBER]

[DATE]

[FDA ADDRESSEE]

Re: Request for waiver of full Institutional Review Board (IRB) review of non-emergency individual patient expanded access investigational new drug application (IND) for [INSERT DRUG NAME AND IND NUMBER (if available)]

Dear [NAME OF ADDRESSEE]:

[FOR INITIAL SUBMISSIONS]

I request authorization to obtain concurrence by the IRB chairperson or by a designated IRB member before the treatment with [INSERT DRUG NAME] begins, to comply with FDA’s requirements for IRB review and approval.  This concurrence would be in lieu of review and approval of an individual patient expanded access IND at a convened IRB meeting at which a majority of the members are present.

[FOR AMENDMENTS TO AN INITIAL SUBMISSION THAT HAD FULL IRB APPROVAL]

I have been treating a patient with [INSERT DRUG NAME] under IND [INSERT IND NUMBER] since [INSERT DATE].  The initial IRB approval of the IND was granted at a convened IRB meeting at which a majority of the members were present. 

Enclosed is an amendment to the IND to [INCLUDE A BRIEF SUMMARY OF THE AMENDMENT, e.g., CONTINUE THE TREATMENT FOR ADDITIONAL TIME, CHANGE THE DOSE OF THE DRUG].  I request authorization to obtain concurrence by the IRB chairperson or by a designated IRB member hereafter, under the amended protocol, to comply with FDA’s requirements for IRB review and approval.  This concurrence would be in lieu of review and approval of an individual patient expanded access IND at a convened IRB meeting at which a majority of the members are present.

If you have any questions, please contact me at [INSERT TELEPHONE NUMBER]. 

Sincerely,

[INSERT SIGNATURE OF RESPONSIBLE OFFICIAL]

[INSERT NAME OF RESPONSIBLE OFFICIAL]

[INSERT RESPONSIBLE OFFICIAL’S TITLE]

[INSERT RESPONSIBLE OFFICIAL’S FAX NUMBER]

[INSERT RESPONSIBLE OFFICIAL’S E-MAIL ADDRESS]

1.Form FDA 1571: Investigational New Drug Application (IND).
2.FDA intends to consider a completed Form FDA 3926 (Individual Patient Expanded Access Investigational New Drug Application (IND)) with the box in Field 10.b checked and the form signed by the physician as a request for waiver. A waiver request letter is not needed in such case.

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