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Placement of DMF Reference Letters

Rather than submit key information in Module 3 of an application (ANDA, BLA, IND, or NDA), it’s become increasingly common for sponsors to reference a Drug Master File (DMF). Referencing a DMF allows the component manufacturer of the drug or biologic to share proprietary information with the US FDA without having to directly share the information with the sponsor.

When referencing a DMF, both the referenced party (DMF owner) and the referencing party (the application’s sponsor) must appropriately inform the FDA. The instructions to FDA, typically delivered as a Letter of Authorization (LOA), should reside in either section 1.4.1 Letter of Authorization or section 1.4.2 Statement of Right of Reference of the eCTD application.

Placement of DMF Reference Letters
Graphic 1: Submit DMF Reference Letters in either Section 1.4.1 Letter of Authorization or Section 1.4.2 Statement of Right of Reference.

Which section should you choose? Our experience is that sponsors get this wrong more often than not. Here’s how to remember the appropriate placement for the LOA:

  • If you own a DMF and are authorizing a sponsor to reference it, submit the LOA in section 1.4.1 in Module 1 of your DMF submission
  • If you are the sponsor who is referencing the DMF, submit a copy of the LOA in section 1.4.2 in Module 1 of your application
Flow Chart for DMF Reference Letters
Graphic 2: This chart depicts the proper procedure for submitting DMF Reference letters

Sponsors who are referencing another application they own (not a DMF) should also use this convention. Simply place the LOA in section 1.4.1 of the application that is to be referenced. Then, place a copy of the LOA in section 1.4.2 of the application that is making the reference.

Follow these best practices for placement of DMF reference letters to keep your DMFs and applications well organization. Your intentions will be abundantly clear to the FDA.

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