Fillable Printable Letter of Authorization (LOA) for your customer

Letter of Authorization (LOA) for your customer

LETTER OF AUTHORIZATION (LOA)

Date: Enter the Submission date of the LOA

DMF#: Enter the DMF number

Holder: Enter the Name of Holder

Subject (Title): Enter the Subject (Title)of the DMF as it appears on the DMF Web site.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/Drug

MasterFilesDMFs/default.htm

Letter of Authorization for: Enter the name of the Item being Referenced*

Dear DMF Staff:

HOLDER hereby authorizes AUTHORIZED PARTY** to incorporate by reference information

regarding Item in DMF NUMBER into any APPLICATION*** filed by AUTHORIZED PARTY.

We also authorize the FDA to review the aforementioned specific information in DMF NUMBER

when considering any APPLICATION filed by AUTHORIZED PARTY.

Identify specific Information to be referenced or entire DMF, where applicable. (Note: Do not

include the Volume number.)

Include:

Name of Item e.g. elastomer formulation, polymer formulation

Date of Submission of Item to FDA

Page number and/or Sections within Submission to FDA.

HOLDER states that DMF NUMBER is current and HOLDER will comply with the statements

made within it. HOLDER will notify FDA through an amendment to DMF Number of any

addition, change, or deletion of information in the DMF. HOLDER will also notify in writing

AUTHORIZED PARTY that an addition, change, or deletion of information has been made to the

DMF.

Sincerely,

Signature of Responsible Official

Enter

Name of Responsible Official

Responsible Official’s Title

Responsible Official’s Company i.e. Holder or Agent

Responsible Official’s Telephone number

Responsible Official’s Fax number

Responsible Official’s e-mail address

Notes

* For DMFs that cover multiple items, e.g. different elastomer formulations, it is important

to specify the name of the item and the location within the DMF. Do not include the volume

number.

** The Authorized Party is the Applicant or Sponsor or DMF holder whose Application

references the DMF

*** An Application can be a New Drug Application (NDA), Abbreviated New Drug

Application (ANDA), Investigational New Drug Application (IND), New Animal Drug

Application (NADA), Biological License Application (BLA), or another DMF. The actual

Application number may be specified, if desired.

For paper DMFs, all LOAs MUST be submitted in two copies to the DMF.

A copy of the LOA MUST be sent to the Authorized Party.

Submission of an LOA does NOT permit the Authorized Party to examine the DMF. The

FDA does not have open and closed parts of DMFs.

All LOAs must have a DMF number.