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                Expanded Access

Expanded Access

                        Expanded Access | Information for Patients
          Expanded Access | Information for Physicians
          Expanded Access | Information for Industry
          Expanded Access | How to Submit a Request (Forms)
          Expanded Access | Keywords, Definitions, and Resources
          Expanded Access (Compassionate Use) Submission Data
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          Expanded Access
          Example of Wording for Letter of Authorization (LOA) For Individual Patient Expanded Access INDExpanded Access Example of Wording for Letter of Authorization (LOA) For Individual Patient Expanded Access IND
  
  	
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    Print[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]

Resources For You

Visit the Expanded Access (Compassionate Use) Main Page

                                                                                  Content current as of:
      01/04/2018Expanded Access

          
                        Information for Patients
          Information for Physicians
          Information for Industry
          How to Submit a Request (Forms)
          Keywords, Definitions, and Resources
          Submission Data
          Contact Information
 
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