I'm looking for an explanation on how to submit a Drug Master File with the FDA and how the process works. An example would be very helpful.

Thanks,
Brandy:)

I'm looking for an explanation on how to submit a Drug Master File with the FDA and how the process works. An example would be very helpful.

Thanks,
Brandy:)I doubt you will get an example since the file usually contains proprietary information. I'm not in pharma so I haven't had experience with this, but there is guidance (http://www.fda.gov/cder/guidance/dmf.htm) on the FDA website. (http://www.fda.gov/cder/guidance/)

Since this post was some time ago, you may have received an answer. I have prepared over 50 DMF's world wide and have resources available to you. Please contact me if still interested.

Since this post was some time ago, you may have received an answer. I have prepared over 50 DMF's world wide and have resources available to you. Please contact me if still interested.

Why not post some samples here?

Stijloor.

Stijour - Good Point!
However, as with most regulatory paperwork, it is not that simple. To get started however, one must use the ICH Common Technical Document (CTD) format for quality utilizing Modules 1, 2 (Quality Overall Summary (QOS), and Module 3.2 both in the "Applicants" part and the "Restricted" part. This information is found in the ICH.org website. For the FDA, all parts are placed together. There is a whitepaper available from Rondaxe Pharma that explains how to prepare in detail.
Different countries have different requirements and forms but all want the CTD format.

Do you have a copy of that whitepaper? I googled it and tried to download the whitepaper from the resulting location but it does not come through.

I'm working for a company that has a bunch o' DMFs from a long time ago :mg: and I have been tasked with cleaning them up and developing a path forward to plan for how we will file future DMFs so they aren't as cumbersome as our current ones are...:bonk:

Sorry for the delay in gettting back with you.
As a consultant, I can offer my services to you or if you have several to do, then I could update one and give you a template to change the others. The whitepaper is for sale by Rondaxe. I do not have any idea of price. Should the above not be workable for you, I would suggest looking at the ICH M4 guidance (granularity) and the latest DMF recommendations on the CDER website.
Best regards,
Tom Warden