Authorization Letter

An Authorization Letter is a letter which clearly permits a CRO, Agency or Consultant to submit various documentation to the FDA on an authorizing company’s behalf.

Requirements

The Letter of Authorization must be submitted on the authorizing company’s letterhead and signed with a traditional handwritten signature by a company employee who is able to make such an agreement on the behalf of the company. This should be saved as a PDF and ideally no larger than 10 MB.

How to Submit Authorization Letters

Authorization Letters are to be uploaded within the Unified Submission Portal (USP) within the User Management module. Each Authorization Letter should be uploaded to the USP by the CRO, Agent, or Consultant company in the Letters section of the company profile and associated with the authorizing company on whose behalf the CRO, Agent, or Consultant company will be submitting. Power Users for the company are the only users with permissions to upload Authorization Letters within the USP.

Physical Letters are No Longer Required

A physical copy of the Authorization Letter is no longer required to be mailed to the FDA. Submitting a physical copy is now optional. Clients who would like to continue to send a physical copy to the FDA can do so by sending the letter to:

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Multiple Sponsoring Organizations

A company can have more than one CRO, Agent, or Consultant company submitting on their behalf. Power Users for each company should ensure that the company is listed as an authorizing company or agent company in the User Management module.

Sample: Letter of Authorization

The following letter is provided as a sample for an Authorization Letter. The information in square brackets [ ] will be provided by the submitter.

SAMPLE LETTER

[Company Letterhead]

[Today's Date]

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Re: Authorization Letter

To whom it may concern:

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, please accept this Authorization Letter. This letter is to certify that [Client Company Name] authorizes [Your Company Name] to submit in the Electronic Submissions Gateway on behalf of [Client Company Name].

Sincerely yours,

[Hand-written signature]
[Company Representative Title]