Drug Master Files (DMFs)
Thermo Fisher Scientific has submitted Drug Master Files to the US Food & Drug Administration for many of our products. Wherever you are in the world, contact our industry-leading regulatory experts to cross-reference a DMF or to provide regulatory support files.
DMF Authorizations for submissions to Health Canada can be supported upon request with a 4 to 6 week submission period.
A Drug Master File (DMF) or master file is a submission to the Food and Drug Administration (FDA) or Health Canada that may be used to provide confidential, detailed information about facilities, processes or articles employed in the manufacturing, processing, packaging and storing of one or more drugs intended for use in humans or animals. Neither law nor FDA regulations require the submission of a DMF. The file is submitted solely at the discretion of the holder and is never approved or disapproved. The FDA will review information submitted only upon written request and reference given by the holder of the DMF. The DMF holder provides the written authorization to the FDA that allows the review of the Master File to support another regulatory application. The information contained in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), a Biologics License Application (BLA), another DMF or amendments to any of these. Thermo Fisher Scientific submits DMFs on those products that have significant potential to be used in a manufacturing environment by our customers. There are several types of DMFs; we submit Type II files which are classified as either "Drug Substance," "Drug Substance Intermediate," or "Material" (used in the preparation of a drug product).
DMF letter of authorization
As a Thermo Fisher Scientific customer using one of our Gibco products in a manufacturing process, you may request that we provide reference authorization to our Drug Master File(s) in support of a submission or filing that you have made to the FDA. To initiate the reference authorization of our DMF, you must submit a Letter of Authorization request to Thermo Fisher Scientific requesting that we provide a DMF Letter of Authorization to the respective FDA Center. Once we have your request, we will advise the FDA that a Thermo Fisher Scientific Drug Master File is relevant to its review and that the agency has our approval to make that DMF part of your submission./p>
All information contained in a Drug Master File is considered confidential to the holder. Neither the FDA nor other outside party may have access to or release the file without the holder's consent.
For further inquiries, contact LSG.Regulatory@thermofisher.com