ESG User Guide - Table of Contents

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. Clients must send an electronic copy of the Letter of Authorization to [email protected]. In addition, clients must send a physical copy to the FDA. A hard copy of the Letter of Authorization must be sent within 2 weeks. The letter must be sent to:

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

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]

Lowell Marshall
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]