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View Full Version : Has anyone evr had to submit a DMF (Drug Master File) with the FDA?

brgreath
16th February 2006, 08:50 AM
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:)
Al Rosen
16th February 2006, 02:51 PM
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/)