Authorization Letter

Clients must submit a Letter of Authorization to the FDA for CROs, U.S. Agents or Consultants. The Letter of Authorization must be submitted on company letterhead and signed with a traditional handwritten signature. Authorization Letters are to be uploaded within the Unified Submission Portal (USP) within the User Management module. Power Users for the company are the only users with permissions to upload Authorization Letters within the USP. Clients are no longer required to submit a physical copy 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

Samples: 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]