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Example of Wording for Letter of Authorization (LOA) For Individual Patient Expanded Access IND

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


[DATE]


[FDA ADDRESSEE]


Re: Letter of Authorization to Cross Reference to IND [INSERT DRUG NAME AND IND NUMBER]


Dear [NAME OF ADDRESSEE]:

This letter of authorization (LOA) authorizes [INSERT PHYSICIAN SPONSOR’S NAME] to reference and rely on [INSERT COMPANY’S NAME] IND [INSERT IND NUMBER] in connection with [INSERT PHYSICIAN SPONSOR’S NAME] individual patient expanded access IND [INSERT RELEVANT INFORMATION DESCRIBING PHYSICIAN SPONSOR’S IND].


FDA is authorized to refer to [INSERT COMPANY’S NAME] IND [INSERT IND NUMBER] for the purpose of FDA’s review of the IND submitted by [INSERT PHYSICIAN SPONSOR’S NAME] and described above.


As indicated by my signature below, I am authorized to provide this LOA on behalf of [INSERT COMPANY NAME], and my full name, title, address, email address, telephone number, and facsimile number are set out below for verification.


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]

Page Last Updated: 02/04/2015
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