2 replies to this topic

[johnwhittaker]

I have recently been asked by my Boss, to research the above mentioned topic. Does anyone out there have any experience or knowledge that they would like to share with me, as i have been on the FDA website and i'm afraid to say it has left me confused to say the least!!!
John

[Simon]

Hi John,

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.

Do I sound like I know what I'm talking about? I don't I got the information from here:

http://www.fda.gov/c...uidance/dmf.htm

Regards,
Simon

[johnwhittaker]

Simon,


I too have been on that website, and have to say it left me even more confused afterwards than i was before