Re: Has anyone evr had to submit a DMF (Drug Master File) with the FDA?
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.